FDA Approvals
Welcome to our special section for new drugs and medical devices on the
Drug and Medical Device Approval page. Here, you find a summary of
drugs and medical devices approved by the Food and Drug Administration
(FDA). For more information, click on links to the FDA Web site.
This page was last updated on April 03, 2006
| Date |
Generic Name |
Trade Name |
Details |
| May 11, 2006 |
varenicline tartrate |
Chantix ® tablets |
 |
| May 3, 2006 |
decitabine |
Dacogen injection |
|
| March 16, 2006 |
tool for cancer detection |
LUMA Cervical Imaging System |
|
| March 1, 2006 |
cetuximab |
Erbitux |
|
| February 28, 2006 |
selegiline |
Emsam |
|
| February 22, 2006 |
generic version of the brand name drug Flonase |
Fluticasone Propionate Nasal Spray, the first generic version of the brand name drug Flonase |
|
| February 21, 2006 |
anidulafungin |
Eraxis |
|
| February 3, 2006 |
rotavirus vaccine |
RotaTeq |
|
| February 3, 2006 |
laboratory test to diagnose strains of influenza |
Influenza A/H5 (Asian lineage) Virus Real-time RT-PCR Primer and Probe Set |
|
| January 31, 2006 |
lubiprostone |
Amitiza |
|
| January 31, 2006 |
ranolazine |
Ranexa |
|
| January 27, 2006 |
insulin human [rDNA origin] inhalation powder |
Exubera |
|
| January 26, 2006 |
sunitinib |
Sutent |
|
| January 9, 2006 |
immune globulin subcutaneous (human) |
Vivaglobin |
|
| November 9, 2005 |
deferasiro |
Exjade |
|
| November 4, 2005 |
generic version of Epivir oral solution 10 mg/mL |
Lamivudine oral solution 10 mg/mL |
|
| October 31, 2005 |
nelarabine |
Arranon |
|
| September 21, 2005 |
silicone gel-filled breast implants |
none available |
|
| August 31, 2005 |
flu vaccine |
Fluarix |
|
| August 22, 2005 |
blood test |
Invader UGT1A1 Molecular Assay |
|
| July 28, 2005 |
silicone gel-filled breast implants |
MemoryGel silicone gel-filled breast implants |
|
| July 13, 2005 |
zidovudine |
First generic version of the already-approved Retrovir brand |
|
| July 8, 2005 |
lamivudine and zidovudine |
First generic version of the already-approved Combivir brand |
|
| June 10, 2005 |
tetanus toxoid (T), reduced diphtheria toxoid (d) and acellular pertussis vaccine (ap), adsorbed |
Adacel |
|
| May 9, 2005 |
DNA test |
The Tag-It Cystic Fibrosis Kit |
|
| May 5, 2005 |
ropinirole |
Requip |
|
| May 3, 2005 |
tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed |
Boostrix |
|
| April 18, 2005 |
prescription oral rinse |
Oral Rinse |
|
| April 7, 2005 |
Product to protect against leakage of cerebrospinal fluid after brain surgery |
DuraSeal Dural Sealant System |
|
| March 30, 2005 |
entecavir |
Baraclude |
|
| March 23, 2005 |
Endovascular grafting system for treating a certain kind of aneurysm |
GORE TAG Endoprosthesis System |
|
| March 17, 2005 |
pramlintide acetate |
Symlin |
|
| March 16, 2005 |
temozolomide |
Temodar |
|
| February 18, 2005 |
Intravenous drug |
Vaccinia Immune Globulin Intravenous (VIGIV) |
|
| January 31, 2005 |
Fentanyl transdermal system |
Generic version of Alza Corporation's Duragesic Patch (Fentanyl Transderma). |
|
| January 25, 2005 |
Lamivudine/zidovudine fixed dose combination tablets and nevirapine tablets |
No trade name given |
|
| December 23, 2004 |
DNA microarray test |
AmpliChip Cytochrome P450 Genotyping Test |
|
| December 20, 2004 |
Pegaptanib sodium injection |
Macugen |
|
| December 16, 2004 |
Trypan blue ophthalmic solution |
Vision Blue |
|
| December 15, 2004 |
palifermin |
Kepivance |
|
| November 23, 2004 |
natalizumab |
Tysabri |
|
| November 19, 2004 |
surgical marker tag |
SurgiChip Tag Surgical Marker system |
|
| November 19, 2004 |
erlotinib |
Tarceva |
|
| October 26, 2004 |
Artificial spinal disc |
Charité artificial disc |
|
| October 22, 2004 |
Device to destroy uterine fibroids |
ExAblate 2000 System |
|
| October 18, 2004 |
Partial artificial heart |
CardioWest Total Artificial Heart |
|
| September 24, 2004 |
hydromorphone hydrochloride |
Palladone |
|
| September 16, 2004 |
Home defibrillator |
HeartStart Home Defibrillator |
|
| September 13, 2004 |
an intraocular lens |
The Artisan |
|
| September 7, 2004 |
duloxetine hydrochloride |
Cymbalta |
|
| August 25, 2004 |
Blood test for newborns |
The NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit |
|
| August 11, 2004 |
Two drugs including pentetate calcium trisodium injection and pentetate zinc trisodium injection |
Ca-DTPA and Zn-DTPA |
|
| August 3, 2004 |
injectable filler |
Sculptra |
|
| August 2, 2004 |
abacavir/lamivudine and tenofovir disoproxil/emtricitabine |
Epzicom and Truvada |
|
| July 29, 2004 |
acamprosate |
Campral |
|
| July 20, 2004 |
Botulinum Toxin Type A |
Botox |
|
| July 15, 2004 |
imiquimod |
Aldara |
|
| July 12, 2004 |
Imaging tool for detection of lung cancer |
ImageChecker CT CAD software system |
|
| July 7, 2004 |
Device for heart surgery |
Da Vinci Endoscopic Instrument Control System |
|
| June 28, 2004 |
Medicinal leeches |
Leeches |
|
| May 19, 2004 |
azacitidine |
Vidaza |
|
| May 19, 2004 |
docetaxel |
Taxotere |
|
| May 6, 2004 |
hyaluronidase for injection |
Vitrase |
|
| April 21, 2004 |
apomorphine |
Apokyn |
|
| March 26, 2004 |
A rapid HIV diagnostic test kit |
OraQuick Rapid HIV-1/2 Antibody Test |
|
| March 23, 2004 |
Oxycodone hydrochloride extended-release products |
Generic versions |
|
| March 8, 2004 |
cinacalcet |
Sensipar |
|
| February 26, 2004 |
bevacizumab |
Avastin |
|
| February 26, 2004 |
A ventricular assist device (heart pump for children) |
DeBakey VAD Child |
|
| February 12, 2004 |
cetuximab |
Erbitux |
|
| February 5, 2004 |
pemetrexed disodium |
Alimta |
|
| December 17, 2003 |
Test kits for genetic clotting risk |
The Factor V Leiden kit and the Factor II (prothrombin) G20210A kit |
|
| December 12, 2003 |
hyaluronic acid |
Restylane |
|
| December 9, 2003 |
Test kit for anthrax |
The Redline Alert test |
|
| November 25, 2003 |
abarelix |
Plenaxis |
|
| November 21, 2003 |
tadalafil |
Cialis |
|
| November 14, 2003 |
ethinyl estradiol and norethindrone |
Ovcon 35 |
|
| October 17, 2003 |
memantine |
Namenda |
|
| October 10, 2003 |
estradiol topical emulsion |
Estrasorb |
|
| October 8, 2003 |
eplerenone |
Inspra |
|
| October 2, 2003 |
ferric (III) hexacyanoferrate (II) |
Radiogardase |
|
| September 12, 2003 |
daptomycin for injection |
Cubicin |
|
| September 5, 2003 |
ethinyl estradiol and levonorgestrel |
Seasonale |
|
| August 19, 2003 |
vardenafil |
Levitra |
|
| August 13, 2003 |
Stair-climbing wheelchair |
INDEPENDENCE iBOT 3000 Mobility System |
|
| August 12, 2003 |
rosuvastatin |
Crestor |
|
| August 4, 2003 |
porfimer sodium |
Photofrin |
|
| July 25, 2003 |
None |
ADVATE Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method (rAHF-PFM) |
|
| July 24, 2003 |
etanercept |
Enbrel |
|
| July 18, 2003 |
None |
PLAC |
|
| July 9, 2003 |
None |
West Nile Virus IgM Capture ELISA |
|
| July 7, 2003 |
None |
Medtronic MiniMed Paradigm insulin pump with a Becton Dickinson glucose monitor |
|
| June 25, 2003 |
pravastatin sodium/buffered aspirin |
Pravigard PAC |
|
| June 20, 2003 |
atropine autoinjector |
Atropen |
|
| June 20, 2003 |
omalizumab |
Xolair |
|
| June 20, 2003 |
atazanavir sulfate |
Reyataz |
|
| June 17, 2003 |
Influenza virus vaccine live, intranasal |
FluMist |
|
| May 20, 2003 |
imatinib mesylate |
Gleevec |
|
| May 16, 2003 |
none |
Platelia Aspergillus EIA |
|
| May 15, 2003 |
none |
Biotronik's implantable cardioverter defibrillator |
|
| May 13, 2003 |
bortezomib |
Velcade |
|
| May 5, 2003 |
gefitinib |
Iressa |
|
| May 1, 2003 |
none |
NIOX Nitric Oxide Test System |
|
NOTE: Click on the to read the details of the approval.
| Date |
: |
May 11, 2006 |
| Generic Name |
: |
varenicline tartrate |
| Trade Name |
: |
Chantix ® tablets |
| Manufacturer |
: |
Pfizer, Inc. |
| Type of Drug/Product |
: |
smoking cessation medication |
| FDA Release |
: |
The FDA announced approval of Chantix, a smoking cessation tablet. It
acts at sites in the brain affected by nicotine and may help those who
wish to give up smoking in two ways. It provides some nicotine effects
to ease the withdrawal symptoms and also blocks the effects of nicotine
from cigarettes if the user resumes smoking. |
| Date |
: |
May 3, 2006 |
| Generic Name |
: |
decitabine |
| Trade Name |
: |
Dacogen injection |
| Manufacturer |
: |
Pharmachemie B.V. Haarlem, The Netherlands for MGI PHARMA, INC., Bloomington, MN. |
| Type of Drug/Product |
: |
treatment for myelodysplastic syndromes |
| FDA Release |
: |
The
FDA approved Dacogen (decitabine) injection for the treatment of
myelodysplastic syndromes. Dacogen is a new molecular entity that
received orphan drug status. Orphan products are developed to treat
rare diseases or conditions that affect fewer than 200,000 people in
the U.S. The Orphan Drug Act provides a seven-year period of exclusive
marketing to the first sponsor who obtains marketing approval for a
designated orphan drug. |
| Date |
: |
March 16, 2006 |
| Generic Name |
: |
tool for cancer detection |
| Trade Name |
: |
LUMA Cervical Imaging System |
| Manufacturer |
: |
MediSpectra, Inc. |
| Type of Drug/Product |
: |
tool to help catch cervical cancer |
| FDA Release |
: |
The
FDA approved a new imaging system that can help detect a cervical
cancer precursor, an indication that cancer is developing, by
identifying sites on the cervix that may have pre-cancerous cells. |
| Date |
: |
March 1, 2006 |
| Generic Name |
: |
cetuximab |
| Trade Name |
: |
Erbitux |
| Manufacturer |
: |
ImClone Systems Inc. |
| Type of Drug/Product |
: |
treatment of squamous cell cancer of the head and neck |
| FDA Release |
: |
The FDA announced the approval of Erbitux for use in combination with
radiation therapy to treat patients with squamous cell cancer of the
head and neck that cannot be treated with surgery. Erbitux was also
approved for use alone to treat patients whose head and neck cancer has
spread despite using standard chemotherapy. |
| Date |
: |
February 28, 2006 |
| Generic Name |
: |
selegiline |
| Trade Name |
: |
Emsam |
| Manufacturer |
: |
Bristol-Myers Squibb |
| Type of Drug/Product |
: |
treatment for depression |
| FDA Release |
: |
Emsam,
the first skin patch for treating major depression, was approved by the
FDA. The once-a-day patch works by delivering selegiline, a monoamine
oxidase inhibitor (MAOI), through the skin and into the bloodstream. At
its lowest strength, Emsam can be used without the dietary restrictions
that are needed for MAOIs taken by mouth. |
| Date |
: |
February 22, 2006 |
| Generic Name |
: |
generic version of the brand name drug Flonase |
| Trade Name |
: |
Fluticasone Propionate Nasal Spray, the first generic version of the brand name drug Flonase |
| Manufacturer |
: |
Roxane Laboratories of Columbus, OH |
| Type of Drug/Product |
: |
treats the nasal symptoms of seasonal and chronic (long-lasting) allergic and nonallergic rhinitis |
| FDA Release |
: |
The
FDA approved Fluticasone Propionate Nasal Spray, the first generic
version of the brand name drug Flonase, giving American consumers an
additional, lower cost alternative when choosing prescription drug
products. |
| Date |
: |
February 21, 2006 |
| Generic Name |
: |
anidulafungin |
| Trade Name |
: |
Eraxis |
| Manufacturer |
: |
Pfizer Inc. of New York, NY. |
| Type of Drug/Product |
: |
treatment of infections caused by a certain fungus |
| FDA Release |
: |
The
FDA approved Eraxis to treat certain infections caused by Candida, a
yeast-like fungus that can cause serious infections in hospitalized
patients or patients with compromised immune systems. |
| Date |
: |
February 3, 2006 |
| Generic Name |
: |
rotavirus vaccine |
| Trade Name |
: |
RotaTeq |
| Manufacturer |
: |
Merck & Co., Inc. |
| Type of Drug/Product |
: |
A live oral vaccine for use in preventing rotavirus gastroenteritis in infants |
| FDA Release |
: |
The
FDA approved RotaTeq, which can help protect against rotavirus, a viral
infection that may cause diarrhea, vomiting, fever and dehydration.
Infection with rotavirus is a leading cause of severe diarrhea in
infants and young children in the United States and worldwide. |
| Date |
: |
February 3, 2006 |
| Generic Name |
: |
laboratory test to diagnose strains of influenza |
| Trade Name |
: |
Influenza A/H5 (Asian lineage) Virus Real-time RT-PCR Primer and Probe Set |
| Manufacturer |
: |
developed
by Centers for Disease Control and Prevention and distributed by
Laboratory Response Network (LRN)-designated laboratories |
| Type of Drug/Product |
: |
laboratory test |
| FDA Release |
: |
The
FDA announced the approval of a new laboratory test to diagnose H5
strains of influenza in patients suspected to be infected with the
virus. The test provides preliminary results on suspected H5 influenza
samples within four hours once a sample arrives at the lab and testing
begins. Previous testing technology would require at least two to three
days to render results. |
| Date |
: |
January 31, 2006 |
| Generic Name |
: |
lubiprostone |
| Trade Name |
: |
Amitiza |
| Manufacturer |
: |
Marketed by Sucampo Pharmaceuticals, Inc., Bethesda, MD., and by Takeda Pharmaceuticals America, Lincolnshire, IL. |
| Type of Drug/Product |
: |
Treatment of chronic constipation in adults when there is no known cause for the condition |
| FDA Release |
: |
The FDA approved Amitiza for the treatment of chronic constipation in
adults when there is no known cause. Chronic idiopathic constipation is
generally defined as infrequent and difficult passage of stool and is
one of the most common disorders suffered by Americans. |
| Date |
: |
January 31, 2006 |
| Generic Name |
: |
ranolazine |
| Trade Name |
: |
Ranexa |
| Manufacturer |
: |
CV Therapeutics, Inc. in Palo Alto, California. |
| Type of Drug/Product |
: |
treatment for chest pain |
| FDA Release |
: |
The FDA approved of Ranexa, the first drug approved to treat chronic
chest pain in over 10 years. It should only be used by people who have
not responded to other drugs used for chest pain - long-acting
nitrates, calcium channel blockers and beta blockers. |
| Date |
: |
January 27, 2006 |
| Generic Name |
: |
insulin human [rDNA origin] inhalation powder |
| Trade Name |
: |
Exubera |
| Manufacturer |
: |
Pfizer Inc. |
| Type of Drug/Product |
: |
treatment of type 1 and type 2 diabetes |
| FDA Release |
: |
Many
of the more than 5 million Americans who take insulin injections now
may have an alternative to injections of insulin. The FDA has approved
the first ever inhaled insulin. Exubera is the first new insulin
delivery option introduced since the discovery of insulin in the 1920s. |
| Date |
: |
January 26, 2006 |
| Generic Name |
: |
sunitinib |
| Trade Name |
: |
Sutent |
| Manufacturer |
: |
Pfizer Labs, Division of Pfizer, Inc. in New York, NY |
| Type of Drug/Product |
: |
cancer treatment for stomach and kidney cancers |
| FDA Release |
: |
The
FDA approved Sutent, a new targeted anti-cancer treatment for patients
with gastrointestinal stromal tumors, a rare stomach cancer, and
advanced kidney cancer. |
| Date |
: |
January 9, 2006 |
| Generic Name |
: |
immune globulin subcutaneous (human) |
| Trade Name |
: |
Vivaglobin |
| Manufacturer |
: |
ZLB Behring GmbH of Marburg, Germany |
| Type of Drug/Product |
: |
The
first immune globulin product for subcutaneous injection for the
prevention of serious infections in people with primary immune
deficiency diseases (PIDD) |
| FDA Release |
: |
The
FDA announced the approval of the first immune globulin product for
subcutaneous injection for the prevention of serious infections in
patients with PIDD. Vivaglobin, from human plasma collected at U.S.
licensed plasma centers, provides new delivery options for these
patients. |
| Date |
: |
November 9, 2005 |
| Generic Name |
: |
deferasiro |
| Trade Name |
: |
Exjade |
| Manufacturer |
: |
Novartis Pharmaceutical Corp. in Stein, Switzerland |
| Type of Drug/Product |
: |
An oral iron chelator developed to treat chronic iron overload due to multiple blood transfusions |
| FDA Release |
: |
The
FDA approved Exjade, which is the first orally administered medication
to be approved for this use. Treatment for iron overload, which can
damage the heart and liver, had previously required daily prolonged
drug infusions lasting eight to12 hours. |
| Date |
: |
November 4, 2005 |
| Generic Name |
: |
generic version of Epivir oral solution 10 mg/mL |
| Trade Name |
: |
Lamivudine oral solution 10 mg/mL |
| Manufacturer |
: |
Aurobindo Pharma LTD. of Hyderabad , India |
| Type of Drug/Product |
: |
Treatment of children ages 3 months to 16 years who have HIV |
| FDA Release |
: |
The
FDA tentatively approved Lamivudine, which is the first generic version
of the already approved Epivir oral solution, 10 mg/mL, manufactured by
GlaxoSmithKline. |
| Date |
: |
October 31, 2005 |
| Generic Name |
: |
nelarabine |
| Trade Name |
: |
Arranon |
| Manufacturer |
: |
GlaxoSmithKline of Research Triangle Park, North Carolina Corporation |
| Type of Drug/Product |
: |
Drug for treatment of adults and children with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma |
| FDA Release |
: |
The
FDA approved Arranon, a new drug to treat adults and children with
T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma,
whose disease has not responded to or has relapsed following at least
two chemotherapy regimens. |
| Date |
: |
September 21, 2005 |
| Generic Name |
: |
silicone gel-filled breast implants |
| Trade Name |
: |
none available |
| Manufacturer |
: |
Inamed Corporation |
| Type of Drug/Product |
: |
silicone gel-filled breast implants |
| FDA Release |
: |
The FDA issued an approvable letter to Inamed for its premarket
application for silicone gel-filled breast implants. An approvable
letter is one of several steps in the FDA review process of new
products. Inamed has provided the FDA with additional information to
address the safety concerns discussed by the panel. This is not an
approval to market the product. |
| Date |
: |
August 31, 2005 |
| Generic Name |
: |
flu vaccine |
| Trade Name |
: |
Fluarix |
| Manufacturer |
: |
Dresden, Germany by Sächsisches Serumwerk, a subsidiary of GlaxoSmithKline Biologicals, of Rixensart, Belgium |
| Type of Drug/Product |
: |
|
| FDA Release |
: |
The FDA approved Fluarix, a flu vaccine for adults that contains
inactivated virus. Fluarix is approved to immunize adults 18 years and
older against flu virus types A and B contained in the vaccine. |
| Date |
: |
August 22, 2005 |
| Generic Name |
: |
blood test |
| Trade Name |
: |
Invader UGT1A1 Molecular Assay |
| Manufacturer |
: |
Third Wave Technologies, Inc., in Madison, Wisconsin |
| Type of Drug/Product |
: |
Test to help some patients make drug treatment decisions |
| FDA Release |
: |
The
FDA cleared the way for marketing a new blood test that will help
doctors make personalized drug treatment decisions for some patients.
The Invader UGT1A1 Molecular Assay detects variations in a gene that
affects how certain drugs are broken down and cleared by the body.
Doctors can use this information to help determine the right drug
dosage for individual patients, and minimize harmful drug reactions. |
| Date |
: |
July 28, 2005 |
| Generic Name |
: |
silicone gel-filled breast implants |
| Trade Name |
: |
MemoryGel silicone gel-filled breast implants |
| Manufacturer |
: |
Mentor Corporation |
| Type of Drug/Product |
: |
silicone gel-filled breast implants |
| FDA Release |
: |
The
FDA issued an approvable letter to Mentor Corporation for their
application for silicone gel-filled breast implants. Federal law and
regulations prohibit the government from discussing the specific
contents of the letter. However, an approvable letter is one of several
intermediate steps in the FDA review process of new products. This
letter does not mean that the device is approved for marketing in the
United States at this time. |
| Date |
: |
July 13, 2005 |
| Generic Name |
: |
zidovudine |
| Trade Name |
: |
First generic version of the already-approved Retrovir brand |
| Manufacturer |
: |
Ranbaxy Laboratories Limited of Guragon, India |
| Type of Drug/Product |
: |
Helps keep the AIDS virus from reproducing |
| FDA Release |
: |
The
FDA announced the tentative approval of zidovudine tablets, which
contain 300 mg of zidovudine in each tablet, and is the first generic
version of the already-approved Retrovir brand of the product
manufactured by GlaxoSmithKline. |
| Date |
: |
July 8, 2005 |
| Generic Name |
: |
lamivudine and zidovudine |
| Trade Name |
: |
First generic version of the already-approved Combivir brand |
| Manufacturer |
: |
Aurobindo Pharma Ltd. of Hyderabad, India |
| Type of Drug/Product |
: |
Treatment of AIDS - helps keep the AIDS virus from reproducing |
| FDA Release |
: |
The
FDA tentatively approved the fixed-dose combination drug product
containing 150 milligrams of lamivudine and 300 mg of zidovudine in
each tablet. It is the first generic version of the already-approved
Combivir brand. |
| Date |
: |
June 10, 2005 |
| Generic Name |
: |
tetanus toxoid (T), reduced diphtheria toxoid (d) and acellular pertussis vaccine (ap), adsorbed |
| Trade Name |
: |
Adacel |
| Manufacturer |
: |
Aventis Pasteur Limited located in Toronto, Canada |
| Type of Drug/Product |
: |
Single booster immunization against whooping cough, in combination with tetanus and diphtheria |
| FDA Release |
: |
The
FDA approved a new vaccine for a single booster immunization against
whooping cough, in combination with tetanus and diphtheria, for people
11 to 64 years old. Adacel is the first vaccine approved as a whooping
cough booster for adults. |
| Date |
: |
May 9, 2005 |
| Generic Name |
: |
DNA test |
| Trade Name |
: |
The Tag-It Cystic Fibrosis Kit |
| Manufacturer |
: |
Tm Bioscience Corporation of Toronto, Canada. |
| Type of Drug/Product |
: |
DNA test to identify cystic fibrosis |
| FDA Release |
: |
The first DNA-based blood test was approved to help detect cystic fibrosis. |
| Date |
: |
May 5, 2005 |
| Generic Name |
: |
ropinirole |
| Trade Name |
: |
Requip |
| Manufacturer |
: |
GlaxoSmithKline |
| Type of Drug/Product |
: |
Treatment of restless legs syndrome |
| FDA Release |
: |
Requip was approved to treat moderate to severe restless legs syndrome. |
| Date |
: |
May 3, 2005 |
| Generic Name |
: |
tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed |
| Trade Name |
: |
Boostrix |
| Manufacturer |
: |
GlaxoSmithKline |
| Type of Drug/Product |
: |
Combination vaccine that gives teens a booster immunization against whooping cough along with tetanus and diphtheria |
| FDA Release |
: |
The
FDA approved the first combination vaccine that gives a booster
immunization to teens against whooping cough in combination with
tetanus and diphtheria for adolescents. |
| Date |
: |
April 18, 2005 |
| Generic Name |
: |
prescription oral rinse |
| Trade Name |
: |
Oral Rinse |
| Manufacturer |
: |
Sinclair Pharmaceuticals Limited, based in the United Kingdom. |
| Type of Drug/Product |
: |
treatment for gingivitis |
| FDA Release |
: |
The
FDA approved a prescription treatment for gingivitis. Decapinol treats
gingivitis by reducing the number of bacteria that attach to tooth
surfaces and cause dental plaque. |
| Date |
: |
April 7, 2005 |
| Generic Name |
: |
Product to protect against leakage of cerebrospinal fluid after brain surgery |
| Trade Name |
: |
DuraSeal Dural Sealant System |
| Manufacturer |
: |
Confluent Surgical, Inc. |
| Type of Drug/Product |
: |
Product protects against leakage of cerebrospinal fluid |
| FDA Release |
: |
The
FDA approved a new product to protect against leakage of cerebrospinal
fluid (CSF) after brain surgery. The DuraSeal Dural Sealant System is
used in dura mater surgery and is applied over sutures (stitches) to
prevent CSF fluid from leaking out of the incision site. Leakage of CSF
can lead to serious complications, such as severe headaches, infection
and meningitis. |
| Date |
: |
March 30, 2005 |
| Generic Name |
: |
entecavir |
| Trade Name |
: |
Baraclude |
| Manufacturer |
: |
Bristol-Myers Squibb Company |
| Type of Drug/Product |
: |
Treatment of chronic hepatitis B in adults |
| FDA Release |
: |
The FDA approved Baraclude tablets and oral solution for treating
chronic hepatitis B in adults. Baraclude slows the progression of
chronic hepatitis B by interfering with viral reproduction. |
| Date |
: |
March 23, 2005 |
| Generic Name |
: |
Endovascular grafting system for treating a certain kind of aneurysm |
| Trade Name |
: |
GORE TAG Endoprosthesis System |
| Manufacturer |
: |
W.L. Gore and Associates, Inc. |
| Type of Drug/Product |
: |
Device to prevent ruptures of descending thoracic aneurysms by making a new path for blood flow |
| FDA Release |
: |
A new device to prevent ruptures of descending thoracic aneurysms by
making a new path for blood flow was approved. The GORE TAG
Endoprosthesis System is the first endovascular grafting system
approved to treat aneurysms of the thoracic aorta, the main artery that
carries blood in the body. |
| Date |
: |
March 17, 2005 |
| Generic Name |
: |
pramlintide acetate |
| Trade Name |
: |
Symlin |
| Manufacturer |
: |
Amylin Pharmaceuticals, Inc. |
| Type of Drug/Product |
: |
Treatment for type 1 and type 2 diabetes |
| FDA Release |
: |
Symlin, an injectable medicine to control blood sugar for adults with
type 1 and type 2 diabetes, was approved by the FDA. Symlin should only
be used with insulin therapy in people who cannot get tight control of
their blood sugar on intensive insulin therapy alone. |
| Date |
: |
March 16, 2005 |
| Generic Name |
: |
temozolomide |
| Trade Name |
: |
Temodar |
| Manufacturer |
: |
Schering-Plough Corporation |
| Type of Drug/Product |
: |
Treatment of brain cancer |
| FDA Release |
: |
The FDA has approved a new indication for Temodar. The drug, used with
radiotherapy and as maintenance therapy after radiotherapy, can extend
the lives of adults newly diagnosed with glioblastoma multiforme, the
most common form of malignant brain cancer. |
| Date |
: |
February 18, 2005 |
| Generic Name |
: |
Intravenous drug |
| Trade Name |
: |
Vaccinia Immune Globulin Intravenous (VIGIV) |
| Manufacturer |
: |
DynPort Vaccine Company LLC |
| Type of Drug/Product |
: |
The first intravenous human plasma-derived product available to treat certain rare complications of smallpox vaccination. |
| FDA Release |
: |
FDA has approved Vaccinia Immune Globulin Intravenous - the first
intravenous human plasma-derived product available to treat certain
rare complications of smallpox vaccination. |
| Date |
: |
January 31, 2005 |
| Generic Name |
: |
Fentanyl transdermal system |
| Trade Name |
: |
Generic version of Alza Corporation's Duragesic Patch (Fentanyl Transderma). |
| Manufacturer |
: |
Mylan Technologies, Inc |
| Type of Drug/Product |
: |
Medication for pain relief |
| FDA Release |
: |
The FDA has approved the first generic version of Alza Corporation's
Duragesic Patch to treat patients suffering from severe chronic pain
that cannot be managed with other pain relievers. |
| Date |
: |
January 25, 2005 |
| Generic Name |
: |
Lamivudine/zidovudine fixed dose combination tablets and nevirapine tablets |
| Trade Name |
: |
No trade name given |
| Manufacturer |
: |
Aspen Pharmacare of South Africa |
| Type of Drug/Product |
: |
antiretroviral drug regimen for treating AIDS |
| FDA Release |
: |
Tentative approval was given for a co-packaged antiretroviral drug regimen for treating HIV-1 infection in adults. |
| Date |
: |
December 23, 2004 |
| Generic Name |
: |
DNA microarray test |
| Trade Name |
: |
AmpliChip Cytochrome P450 Genotyping Test |
| Manufacturer |
: |
Roche Molecular Systems, Inc. |
| Type of Drug/Product |
: |
Test to determine how the body may break down medications |
| FDA Release |
: |
The
Food and Drug Administration approved the first laboratory test system
that allows doctors to consider unique genetic information from
patients in selecting medications and doses for conditions such as
cardiac disease, psychiatric disease and cancer. |
| Date |
: |
December 20, 2004 |
| Generic Name |
: |
Pegaptanib sodium injection |
| Trade Name |
: |
Macugen |
| Manufacturer |
: |
Eyetech Pharmaceuticals, Inc. and Pfizer Inc. Eyetech |
| Type of Drug/Product |
: |
Treatment for age-related macular degeneration |
| FDA Release |
: |
Pegaptanib
sodium injection, a new therapy to slow vision loss in people with the
eye disease neovascular (wet) age-related macular degeneration, was
approved. |
| Date |
: |
December 16, 2004 |
| Generic Name |
: |
Trypan blue ophthalmic solution |
| Trade Name |
: |
Vision Blue |
| Manufacturer |
: |
D.O.R.C. International of the Netherlands |
| Type of Drug/Product |
: |
Product for staining the anterior lens capsule during cataract surgery |
| FDA Release |
: |
Vision
Blue is the first product approved in the United States for staining
the anterior lens capsule during cataract surgery. Vision Blue will
enhance the ability of ophthalmologists (eye surgeons) to remove white
cataracts, a very advanced mature cataract. |
| Date |
: |
December 15, 2004 |
| Generic Name |
: |
palifermin |
| Trade Name |
: |
Kepivance |
| Manufacturer |
: |
Amgen Inc. |
| Type of Drug/Product |
: |
Helps reduce the chance that certain cancer patients will develop mucositis |
| FDA Release |
: |
The
FDA approved an intravenous biologic product palifermin to help reduce
the chance that certain cancer patients (those with blood cancers who
are undergoing chemotherapy and radiation in preparation for bone
marrow transplants) will develop mucositis. Palifermin also shortens
the duration of the condition. |
| Date |
: |
November 23, 2004 |
| Generic Name |
: |
natalizumab |
| Trade Name |
: |
Tysabri |
| Manufacturer |
: |
Biogen Idec, Inc. |
| Type of Drug/Product |
: |
Drug to reduce multiple sclerosis flare-ups |
| FDA Release |
: |
The
first monoclonal antibody treatment for multiple sclerosis was approved
to treat patients with relapsing forms of MS. This drug helps reduce
the frequency of symptom flare-ups. |
| Date |
: |
November 19, 2004 |
| Generic Name |
: |
surgical marker tag |
| Trade Name |
: |
SurgiChip Tag Surgical Marker system |
| Manufacturer |
: |
SurgiChip Inc. |
| Type of Drug/Product |
: |
A single agent treatment for patients with locally advanced or metastatic non-small cell lung cancer |
| FDA Release |
: |
An
external surgical marker tag intended to minimize the likelihood of
wrong-site, wrong-procedure and wrong-patient surgeries was approved by
the FDA. The device is the first such surgical marker to use
radiofrequency identification technology to mark an anatomical site for
surgery. |
| Date |
: |
November 19, 2004 |
| Generic Name |
: |
erlotinib |
| Trade Name |
: |
Tarceva |
| Manufacturer |
: |
Genentech Inc. |
| Type of Drug/Product |
: |
A single agent treatment for patients with locally advanced or metastatic non-small cell lung cancer |
| FDA Release |
: |
A single agent treatment for patients with locally advanced or metastatic non-small cell lung cancer |
| Date |
: |
October 26, 2004 |
| Generic Name |
: |
Artificial spinal disc |
| Trade Name |
: |
Charité artificial disc |
| Manufacturer |
: |
DePuy Spine, Inc. |
| Type of Drug/Product |
: |
Artificial spinal disc |
| FDA Release |
: |
An
artificial spinal disc for treating pain associated with degenerative
disc disease was approved. The device is intended to replace a diseased
or damaged intervertebral disc. |
| Date |
: |
October 22, 2004 |
| Generic Name |
: |
Device to destroy uterine fibroids |
| Trade Name |
: |
ExAblate 2000 System |
| Manufacturer |
: |
InSightec, Ltd. |
| Type of Drug/Product |
: |
Device to destroy uterine fibroids |
| FDA Release |
: |
The
ExAblate 2000 System is a new medical device that uses magnetic
resonance image-guided focused ultrasound to target and destroy uterine
fibroids, non-cancerous masses in the uterus. The device is intended to
treat women who have completed child bearing or do not intend to become
pregnant. |
| Date |
: |
October 18, 2004 |
| Generic Name |
: |
Partial artificial heart |
| Trade Name |
: |
CardioWest Total Artificial Heart |
| Manufacturer |
: |
SynCardia Systems Inc. |
| Type of Drug/Product |
: |
Artificial heart |
| FDA Release |
: |
A
partial artificial heart intended to keep people alive in the hospital
while they are awaiting a heart transplant was approved. The product is
a pulsating biventricular device that is implanted into the chest to
replace the patient's left and right ventricles (the bottom half of the
heart). |
| Date |
: |
September 24, 2004 |
| Generic Name |
: |
hydromorphone hydrochloride |
| Trade Name |
: |
Palladone |
| Manufacturer |
: |
Purdue Pharma L.P., located in Stamford, Conn. |
| Type of Drug/Product |
: |
Management of persistent moderate-to-severe pain in patients requiring around-the-clock opioid pain relief. |
| FDA Release |
: |
The
FDA approved Palladone capsules for managing persistent moderate to
severe pain in people who need around-the-clock opioid pain relief. |
| Date |
: |
September 16, 2004 |
| Generic Name |
: |
Home defibrillator |
| Trade Name |
: |
HeartStart Home Defibrillator |
| Manufacturer |
: |
Philips Medical Systems |
| Type of Drug/Product |
: |
Home defibrillator |
| FDA Release |
: |
The
FDA granted marketing clearance for the first time for the
over-the-counter sale of an automatic external defibrillator designed
specifically for lay users. The device shocks the heart to restore
rhythm in people who are having cardiac arrest. Automatic external
defibrillators treat someone with cardiac arrest whose heart is beating
irregularly (fibrillating). If the heart does not return to a regular
rhythm within five minutes, this fibrillation could be more difficult
to treat or be fatal. |
| Date |
: |
September 13, 2004 |
| Generic Name |
: |
an intraocular lens |
| Trade Name |
: |
The Artisan |
| Manufacturer |
: |
Ophtec USA Inc. |
| Type of Drug/Product |
: |
a plastic lens for nearsightedness |
| FDA Release |
: |
The
FDA approved a plastic lens that is permanently implanted into the eye
to correct moderate to severe nearsightedness. The lens, called an
intraocular lens is similar to the type of lens implanted in the eye to
restore vision following cataract surgery. The new lens is intended to
reduce or eliminate nearsightedness in adults, and will offer people
another alternative to glasses, contact lenses and laser surgery such
as LASIK. |
| Date |
: |
September 7, 2004 |
| Generic Name |
: |
duloxetine hydrochloride |
| Trade Name |
: |
Cymbalta |
| Manufacturer |
: |
Eli Lilly and Company |
| Type of Drug/Product |
: |
treatment of diabetic neuropathy |
| FDA Release |
: |
The
FDA approved Cymbalta capsules for the management of the pain
associated with diabetic peripheral neuropathy. This is the first drug
specifically approved for this condition. |
| Date |
: |
August 25, 2004 |
| Generic Name |
: |
Blood test for newborns |
| Trade Name |
: |
The NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit |
| Manufacturer |
: |
PerkinElmer Life and Analytical Sciences, Inc. of Norton, Ohio. |
| Type of Drug/Product |
: |
A blood test that helps doctors screen newborns for a variety of inherited diseases. |
| FDA Release |
: |
The
FDA cleared a new blood test that helps doctors screen newborns for
inherited diseases. The test is done on blood from newborn heel-stick
samples - the same kind of sample used for state-mandated newborn
screening tests. These diseases can cause developmental delay,
seizures, mental retardation and death. With early identification, many
of the effects of these diseases can be significantly reduced, with
improved long-term outcome and improved quality of life. |
| Date |
: |
August 11, 2004 |
| Generic Name |
: |
Two drugs including pentetate calcium trisodium injection and pentetate zinc trisodium injection |
| Trade Name |
: |
Ca-DTPA and Zn-DTPA |
| Manufacturer |
: |
Hameln Pharmaceuticals, GmbH, of Hameln, Germany. |
| Type of Drug/Product |
: |
Treatment for radioactive contamination |
| FDA Release |
: |
The
Food and Drug Administration approved two drugs, pentetate calcium
trisodium injection (Ca-DTPA) and pentetate zinc trisodium injection
(Zn-DTPA) for treating certain kinds of radiation contamination. The
FDA approved these two drugs to help protect people from illness caused
by nuclear accidents and terrorist threats. Before this approval, there
were no approved drugs for treating internal contamination with
plutonium, americium or curium. |
| Date |
: |
August 3, 2004 |
| Generic Name |
: |
injectable filler |
| Trade Name |
: |
Sculptra |
| Manufacturer |
: |
Dermik Laboratories |
| Type of Drug/Product |
: |
Injectable filler to correct facial fat loss in people with HIV |
| FDA Release |
: |
An
injectible filler called Sculptra is the first treatment approved for a
condition known as lipoatrophy, or facial wasting, a sinking of the
cheeks, eyes and temples caused by the loss of fat tissue under the
skin. Lipoatrophy is common among HIV patients. |
| Date |
: |
August 2, 2004 |
| Generic Name |
: |
abacavir/lamivudine and tenofovir disoproxil/emtricitabine |
| Trade Name |
: |
Epzicom and Truvada |
| Manufacturer |
: |
GlaxoSmithKline makes Epzicom, and Gilead Sciences makes Truvada |
| Type of Drug/Product |
: |
Two fixed-dose combination treatments for HIV-1 infection |
| FDA Release |
: |
The
FDA announced the approvals of Epzicom and Truvada, two fixed-dose
combination treatments for HIV-1 infection. Control of HIV/AIDS
generally requires simultaneous use of three or more drugs from
different classes. Combination products bring together different
HIV/AIDS drugs in a single medication or co-package and help make
treatment regimens less complicated for the patients. |
| Date |
: |
July 29, 2004 |
| Generic Name |
: |
acamprosate |
| Trade Name |
: |
Campral |
| Manufacturer |
: |
Lipha Pharmaceuticals, Inc. in Lyon, France |
| Type of Drug/Product |
: |
Treatment for alcohol dependence |
| FDA Release |
: |
Campral
is available for treating alcohol-dependent people who want to stay
alcohol-free after they have stopped drinking. Campral may not work for
people who are actively drinking at the start of treatment, or in those
who abuse other substances along with alcohol. Campral is the first new
drug approved for alcohol abuse in a decade. |
| Date |
: |
July 20, 2004 |
| Generic Name |
: |
Botulinum Toxin Type A |
| Trade Name |
: |
Botox |
| Manufacturer |
: |
Allergan, Inc. |
| Type of Drug/Product |
: |
Treatment of severe underarm sweating. |
| FDA Release |
: |
The
FDA has approved Botulinum Toxin Type A (Botox) to treat severe
underarm sweating, known as "primary axillary hyperhidrosis," that
cannot be managed by prescription antiperspirants. |
| Date |
: |
July 15, 2004 |
| Generic Name |
: |
imiquimod |
| Trade Name |
: |
Aldara |
| Manufacturer |
: |
3M Pharmaceuticals |
| Type of Drug/Product |
: |
Cream to treat superficial basal cell carcinoma, a type of skin cancer. |
| FDA Release |
: |
The
FDA approved the use of this drug, which treats actinic keratosis and
external genital warts, to also treat superficial basal cell carcinoma
-- a type of skin cancer. |
| Date |
: |
July 12, 2004 |
| Generic Name |
: |
Imaging tool for detection of lung cancer |
| Trade Name |
: |
ImageChecker CT CAD software system |
| Manufacturer |
: |
R2 Technology, Inc. |
| Type of Drug/Product |
: |
Imaging tool for detection of lung cancer |
| FDA Release |
: |
The
FDA approved an image analysis system to help radiologists review
computed tomography images of the chest to help detect solid nodules in
the lungs. Such nodules can be cancerous. |
| Date |
: |
July 7, 2004 |
| Generic Name |
: |
Device for heart surgery |
| Trade Name |
: |
Da Vinci Endoscopic Instrument Control System |
| Manufacturer |
: |
Intuitive Surgical, Inc. |
| Type of Drug/Product |
: |
Device for heart surgery |
| FDA Release |
: |
The
FDA approved the use of a robotic-like system to help surgeons do
coronary artery bypass surgery when there is direct access to the chest
using standard open chest technique or a smaller surgical incision. The
device helps a surgeon perform heart surgery while seated at a console
with a computer and video monitor. |
| Date |
: |
June 28, 2004 |
| Generic Name |
: |
Medicinal leeches |
| Trade Name |
: |
Leeches |
| Manufacturer |
: |
Ricarimpex SAS |
| Type of Drug/Product |
: |
Helps
heal skin grafts by removing blood pooled under the graft and restoring
blood circulation in blocked veins by removing pooled blood. |
| FDA Release |
: |
The Food and Drug Administration has for the first time cleared the
commercial marketing of leeches for medicinal purposes. Leeches can
help heal skin grafts by removing blood pooled under the graft and
restore blood circulation in blocked veins by removing pooled blood. |
| Date |
: |
May 19, 2004 |
| Generic Name |
: |
azacitidine |
| Trade Name |
: |
Vidaza |
| Manufacturer |
: |
Pharmion Corporation |
| Type of Drug/Product |
: |
Treatment for myelodysplastic syndrome. |
| FDA Release |
: |
The FDA approved the first effective treatment for patients with
myelodysplastic syndrome, which is a collection of disorders where the
bone marrow does not function correctly and not enough normal blood
cells are made. The drug restores normal growth of bone marrow cells. |
| Date |
: |
May 19, 2004 |
| Generic Name |
: |
docetaxel |
| Trade Name |
: |
Taxotere |
| Manufacturer |
: |
Aventis Pharmaceuticals Inc. |
| Type of Drug/Product |
: |
For treatment of patients with advanced metastatic prostate cancer. |
| FDA Release |
: |
The
FDA approved Taxotere injection in combination with prednisone (a
steroid) to treat people with advanced metastatic prostate cancer. This
drug can help extend life. |
| Date |
: |
May 6, 2004 |
| Generic Name |
: |
hyaluronidase for injection |
| Trade Name |
: |
Vitrase |
| Manufacturer |
: |
Ista Pharmaceuticals, Inc. |
| Type of Drug/Product |
: |
Used most commonly in combination with local anesthetics for eye surgery. |
| FDA Release |
: |
Vitrase
is an injectable drug approved as an adjunct to (in combination with)
other injected drugs to increase their absorption and dispersion in the
body. Vitrase has been used most commonly in combination with local
anesthetics for eye surgery. Vitrase speeds up the time it takes for an
anesthetic to work. |
| Date |
: |
April 21, 2004 |
| Generic Name |
: |
apomorphine |
| Trade Name |
: |
Apokyn |
| Manufacturer |
: |
Bertek Pharmaceuticals |
| Type of Drug/Product |
: |
Injectable drug for Parkinson's during episodes of "hypomobility," when the patient can't do daily activities. |
| FDA Release |
: |
The
FDA approved Apokyn, an injectable drug used for Parkinson's disease
when patients have "hypomobility," periods where the person can't
perform daily activities because of their symptoms. This is the first
therapy approved to treat these episodes acutely during the episode. |
| Date |
: |
March 26, 2004 |
| Generic Name |
: |
A rapid HIV diagnostic test kit |
| Trade Name |
: |
OraQuick Rapid HIV-1/2 Antibody Test |
| Manufacturer |
: |
OraSure Technologies, Inc. |
| Type of Drug/Product |
: |
For use of oral fluid samples with a rapid HIV diagnostic test kit. |
| FDA Release |
: |
The
FDA approved the use of oral fluid samples with a rapid HIV diagnostic
test kit that is nearly 100 percent accurate, giving results in 20
minutes. Until now, all rapid HIV tests required the use of blood in
order to get such quick results. The test was also approved for
detecting HIV-2 (a variant of HIV common in parts of Africa but rarely
found in the United States) in blood. |
| Date |
: |
March 23, 2004 |
| Generic Name |
: |
Oxycodone hydrochloride extended-release products |
| Trade Name |
: |
Generic versions |
| Manufacturer |
: |
Various |
| Type of Drug/Product |
: |
Management of moderate-to-severe chronic pain. |
| FDA Release |
: |
The
FDA approved two generic oxycodone hydrochloride products and asked
manufacturers to create risk management plans to avoid the potential
for abuse. |
| Date |
: |
March 8, 2004 |
| Generic Name |
: |
cinacalcet |
| Trade Name |
: |
Sensipar |
| Manufacturer |
: |
Amgen |
| Type of Drug/Product |
: |
Treats
secondary hyperparathyroidism in patients with chronic kidney disease
and hypercalcernia in patients with parathyroid cancer |
| FDA Release |
: |
Cinacalcet
is the first drug in the class of compounds known as calcimimetics to
be approved by the FDA. Elevated levels of parathyroid hormone (PTH),
the hallmark of secondary hyperparathyroidism, are associated with
altered metabolism of calcium and phosphorus, bone pain, fractures and
an increased risk for cardiovascular death. The medication lowers serum
levels of PTH. |
| Date |
: |
February 26, 2004 |
| Generic Name |
: |
bevacizumab |
| Trade Name |
: |
Avastin |
| Manufacturer |
: |
Genentech, Inc. |
| Type of Drug/Product |
: |
First line treatment for patients with colon cancer that has spread to other parts of the body |
| FDA Release |
: |
Avastin®
is a first-line treatment for patients with metastatic colorectal
cancer -- cancer that has spread to other parts of the body. Avastin is
the first product to be approved that works by preventing the formation
of new blood vessels, a process known as angiogenesis. Avastin has been
studied, first in the laboratory and then in patients, for three
decades. This is the first such product proven to delay tumor growth
and extend the lives of patients. |
| Date |
: |
February 26, 2004 |
| Generic Name |
: |
A ventricular assist device (heart pump for children) |
| Trade Name |
: |
DeBakey VAD Child |
| Manufacturer |
: |
MicroMed Technology, Inc. |
| Type of Drug/Product |
: |
Heart pump for children ages 5 to 16 |
| FDA Release |
: |
A
miniaturized heart pump for children ages 5 to 16 waiting for a heart
transplant was approved. The product helps the left ventricle of the
heart pump blood. Use of the device may allow children with severe left
ventricle failure to survive long enough to receive a heart transplant. |
| Date |
: |
February 12, 2004 |
| Generic Name |
: |
cetuximab |
| Trade Name |
: |
Erbitux |
| Manufacturer |
: |
Bristol-Myers Squibb Company |
| Type of Drug/Product |
: |
Treatment of advanced colon cancer |
| FDA Release |
: |
Erbitux
(cetuximab) is approved to treat patients with advanced colorectal
cancer that has spread to other parts of the body. Erbitux is the first
monoclonal antibody approved to treat this type of cancer and is
indicated as a combination treatment to be given intravenously with
irinotecan, another drug approved to fight colorectal cancer, or alone
if patients cannot tolerate irinotecan. |
| Date |
: |
February 5, 2004 |
| Generic Name |
: |
pemetrexed disodium |
| Trade Name |
: |
Alimta |
| Manufacturer |
: |
Eli Lilly and Company |
| Type of Drug/Product |
: |
Treatment of malignant pleural mesothelioma |
| FDA Release |
: |
The
Food and Drug Administration (FDA) approved Alimta for use in
combination with cisplatin to treat patients with malignant pleural
mesothelioma-a rare type of cancer. It is the first drug approved for
this condition. |
| Date |
: |
December 17, 2003 |
| Generic Name |
: |
Test kits for genetic clotting risk |
| Trade Name |
: |
The Factor V Leiden kit and the Factor II (prothrombin) G20210A kit |
| Manufacturer |
: |
Roche Diagnostics Corporation of Indianapolis, Ind. |
| Type of Drug/Product |
: |
Tests to identify people with increased risk of developing blood clots in legs |
| FDA Release |
: |
The
new tests help experts identify people who have an increased risk of
developing blood clots in the veins of their legs and elsewhere because
of hereditary abnormalities in two proteins involved in blood clotting. |
| Date |
: |
December 12, 2003 |
| Generic Name |
: |
hyaluronic acid |
| Trade Name |
: |
Restylane |
| Manufacturer |
: |
Q-Med AB of Sweden |
| Type of Drug/Product |
: |
Treatment of facial wrinkles |
| FDA Release |
: |
A new injectable gel is available to treat moderate to severe facial wrinkles. |
| Date |
: |
December 9, 2003 |
| Generic Name |
: |
Test kit for anthrax |
| Trade Name |
: |
The Redline Alert test |
| Manufacturer |
: |
Tetracore, Inc., of Gaithersburg, Md. |
| Type of Drug/Product |
: |
Test to detect anthrax |
| FDA Release |
: |
The test helps doctors distinguish the organism that causes anthrax disease, Bacillus anthracis, from similar organisms. |
| Date |
: |
November 25, 2003 |
| Generic Name |
: |
abarelix |
| Trade Name |
: |
Plenaxis |
| Manufacturer |
: |
Praecis Pharmaceuticals Inc., Waltham, Mass. |
| Type of Drug/Product |
: |
Treatment of the symptoms of men with advanced prostate cancer |
| FDA Release |
: |
The drug treats symptoms of men with advanced prostate cancer who
cannot take other hormone therapies and who have refused surgical
castration. |
| Date |
: |
November 21, 2003 |
| Generic Name |
: |
tadalafil |
| Trade Name |
: |
Cialis |
| Manufacturer |
: |
Lilly ICOS LLC by Eli Lilly and Company |
| Type of Drug/Product |
: |
An oral medication to treat erectile dysfunction in men |
| FDA Release |
: |
This is an oral medication to treat erectile dysfunction and is the third oral product approved for this condition. |
| Date |
: |
November 14, 2003 |
| Generic Name |
: |
ethinyl estradiol and norethindrone |
| Trade Name |
: |
Ovcon 35 |
| Manufacturer |
: |
Bristol Myers Squibb Company of Princeton, N.J. |
| Type of Drug/Product |
: |
Oral contraceptive |
| FDA Release |
: |
Ovcon 35 is an oral, spearmint-flavored contraceptive tablet that can be chewed and swallowed. |
| Date |
: |
October 17, 2003 |
| Generic Name |
: |
memantine |
| Trade Name |
: |
Namenda |
| Manufacturer |
: |
Forest Labs of Jersey City, N.J. |
| Type of Drug/Product |
: |
Treatment of Alzheimer's disease |
| FDA Release |
: |
Memantine is available to treat moderate to severe Alzheimer's disease
and is the first drug approved to treat people with this severity of
disease. |
| Date |
: |
October 10, 2003 |
| Generic Name |
: |
estradiol topical emulsion |
| Trade Name |
: |
Estrasorb |
| Manufacturer |
: |
Novavax |
| Type of Drug/Product |
: |
An estrogen therapy product in a topical form |
| FDA Release |
: |
Estrasorb, an estrogen therapy in a lotion form, treats menopausal hot flashes. |
| Date |
: |
October 8, 2003 |
| Generic Name |
: |
eplerenone |
| Trade Name |
: |
Inspra |
| Manufacturer |
: |
Pfizer Inc. |
| Type of Drug/Product |
: |
The treatment of congestive heart failure |
| FDA Release |
: |
Inspra is approved to improve survival of congestive heart failure patients after a heart attack. |
| Date |
: |
October 2, 2003 |
| Generic Name |
: |
ferric (III) hexacyanoferrate (II) |
| Trade Name |
: |
Radiogardase |
| Manufacturer |
: |
HEYL Chemisch-pharmazeutische Fabrik GmbH & Co. KG. of Berlin, Germany |
| Type of Drug/Product |
: |
Treatment of people exposed to radiation contamination |
| FDA Release |
: |
The first new drug application to treat radiation contamination because of cesium or thallium is approved. |
| Date |
: |
September 12, 2003 |
| Generic Name |
: |
daptomycin for injection |
| Trade Name |
: |
Cubicin |
| Manufacturer |
: |
Cubist Pharmaceutical Inc. |
| Type of Drug/Product |
: |
Treatment of complicated skin and skin structure infections |
| FDA Release |
: |
This
is the first in a class of antibiotics is approved to treat complicated
skin and skin structure infections usually occurring in hospitalized
patients. |
| Date |
: |
September 5, 2003 |
| Generic Name |
: |
ethinyl estradiol and levonorgestrel |
| Trade Name |
: |
Seasonale |
| Manufacturer |
: |
Barr Laboratories |
| Type of Drug/Product |
: |
Oral contraceptives |
| FDA Release |
: |
Seasonale users have fewer scheduled menstrual cycles. |
| Date |
: |
August 19, 2003 |
| Generic Name |
: |
vardenafil |
| Trade Name |
: |
Levitra |
| Manufacturer |
: |
Bayer Corporation |
| Type of Drug/Product |
: |
Treatment of erectile dysfunction |
| FDA Release |
: |
This is the second oral product approved for the treatment of erectile dysfunction. |
| Date |
: |
August 13, 2003 |
| Generic Name |
: |
Stair-climbing wheelchair |
| Trade Name |
: |
INDEPENDENCE iBOT 3000 Mobility System |
| Manufacturer |
: |
Independence Technology |
| Type of Drug/Product |
: |
Wheelchair |
| FDA Release |
: |
Battery-powered
wheelchair relies on a computerized system of sensors, gyroscopes and
electric motors to climb stairs, as well as travel on level and uneven
surfaces. |
| Date |
: |
August 12, 2003 |
| Generic Name |
: |
rosuvastatin |
| Trade Name |
: |
Crestor |
| Manufacturer |
: |
AstraZeneca |
| |
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