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Drug Approvals

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 Details
May 3, 2006 decitabine Dacogen injection Details
March 16, 2006 tool for cancer detection LUMA Cervical Imaging System Details
March 1, 2006 cetuximab Erbitux Details
February 28, 2006 selegiline Emsam Details
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 Details
February 21, 2006 anidulafungin Eraxis Details
February 3, 2006 rotavirus vaccine RotaTeq Details
February 3, 2006 laboratory test to diagnose strains of influenza Influenza A/H5 (Asian lineage) Virus Real-time RT-PCR Primer and Probe Set Details
January 31, 2006 lubiprostone Amitiza Details
January 31, 2006 ranolazine Ranexa Details
January 27, 2006 insulin human [rDNA origin] inhalation powder Exubera Details
January 26, 2006 sunitinib Sutent Details
January 9, 2006 immune globulin subcutaneous (human) Vivaglobin Details
November 9, 2005 deferasiro Exjade Details
November 4, 2005 generic version of Epivir oral solution 10 mg/mL Lamivudine oral solution 10 mg/mL Details
October 31, 2005 nelarabine Arranon Details
September 21, 2005 silicone gel-filled breast implants none available Details
August 31, 2005 flu vaccine Fluarix Details
August 22, 2005 blood test Invader UGT1A1 Molecular Assay Details
July 28, 2005 silicone gel-filled breast implants MemoryGel silicone gel-filled breast implants Details
July 13, 2005 zidovudine First generic version of the already-approved Retrovir brand Details
July 8, 2005 lamivudine and zidovudine First generic version of the already-approved Combivir brand Details
June 10, 2005 tetanus toxoid (T), reduced diphtheria toxoid (d) and acellular pertussis vaccine (ap), adsorbed Adacel Details
May 9, 2005 DNA test The Tag-It Cystic Fibrosis Kit Details
May 5, 2005 ropinirole Requip Details
May 3, 2005 tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed Boostrix Details
April 18, 2005 prescription oral rinse Oral Rinse Details
April 7, 2005 Product to protect against leakage of cerebrospinal fluid after brain surgery DuraSeal Dural Sealant System Details
March 30, 2005 entecavir Baraclude Details
March 23, 2005 Endovascular grafting system for treating a certain kind of aneurysm GORE TAG Endoprosthesis System Details
March 17, 2005 pramlintide acetate Symlin Details
March 16, 2005 temozolomide Temodar Details
February 18, 2005 Intravenous drug Vaccinia Immune Globulin Intravenous (VIGIV) Details
January 31, 2005 Fentanyl transdermal system Generic version of Alza Corporation's Duragesic Patch (Fentanyl Transderma). Details
January 25, 2005 Lamivudine/zidovudine fixed dose combination tablets and nevirapine tablets No trade name given Details
December 23, 2004 DNA microarray test AmpliChip Cytochrome P450 Genotyping Test Details
December 20, 2004 Pegaptanib sodium injection Macugen Details
December 16, 2004 Trypan blue ophthalmic solution Vision Blue Details
December 15, 2004 palifermin Kepivance Details
November 23, 2004 natalizumab Tysabri Details
November 19, 2004 surgical marker tag SurgiChip Tag Surgical Marker system Details
November 19, 2004 erlotinib Tarceva Details
October 26, 2004 Artificial spinal disc Charité artificial disc Details
October 22, 2004 Device to destroy uterine fibroids ExAblate 2000 System Details
October 18, 2004 Partial artificial heart CardioWest Total Artificial Heart Details
September 24, 2004 hydromorphone hydrochloride Palladone Details
September 16, 2004 Home defibrillator HeartStart Home Defibrillator Details
September 13, 2004 an intraocular lens The Artisan Details
September 7, 2004 duloxetine hydrochloride Cymbalta Details
August 25, 2004 Blood test for newborns The NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit Details
August 11, 2004 Two drugs including pentetate calcium trisodium injection and pentetate zinc trisodium injection Ca-DTPA and Zn-DTPA Details
August 3, 2004 injectable filler Sculptra Details
August 2, 2004 abacavir/lamivudine and tenofovir disoproxil/emtricitabine Epzicom and Truvada Details
July 29, 2004 acamprosate Campral Details
July 20, 2004 Botulinum Toxin Type A Botox Details
July 15, 2004 imiquimod Aldara Details
July 12, 2004 Imaging tool for detection of lung cancer ImageChecker CT CAD software system Details
July 7, 2004 Device for heart surgery Da Vinci Endoscopic Instrument Control System Details
June 28, 2004 Medicinal leeches Leeches Details
May 19, 2004 azacitidine Vidaza Details
May 19, 2004 docetaxel Taxotere Details
May 6, 2004 hyaluronidase for injection Vitrase Details
April 21, 2004 apomorphine Apokyn Details
March 26, 2004 A rapid HIV diagnostic test kit OraQuick Rapid HIV-1/2 Antibody Test Details
March 23, 2004 Oxycodone hydrochloride extended-release products Generic versions Details
March 8, 2004 cinacalcet Sensipar Details
February 26, 2004 bevacizumab Avastin Details
February 26, 2004 A ventricular assist device (heart pump for children) DeBakey VAD Child Details
February 12, 2004 cetuximab Erbitux Details
February 5, 2004 pemetrexed disodium Alimta Details
December 17, 2003 Test kits for genetic clotting risk The Factor V Leiden kit and the Factor II (prothrombin) G20210A kit Details
December 12, 2003 hyaluronic acid Restylane Details
December 9, 2003 Test kit for anthrax The Redline Alert test Details
November 25, 2003 abarelix Plenaxis Details
November 21, 2003 tadalafil Cialis Details
November 14, 2003 ethinyl estradiol and norethindrone Ovcon 35 Details
October 17, 2003 memantine Namenda Details
October 10, 2003 estradiol topical emulsion Estrasorb Details
October 8, 2003 eplerenone Inspra Details
October 2, 2003 ferric (III) hexacyanoferrate (II) Radiogardase Details
September 12, 2003 daptomycin for injection Cubicin Details
September 5, 2003 ethinyl estradiol and levonorgestrel Seasonale Details
August 19, 2003 vardenafil Levitra Details
August 13, 2003 Stair-climbing wheelchair INDEPENDENCE iBOT 3000 Mobility System Details
August 12, 2003 rosuvastatin Crestor Details
August 4, 2003 porfimer sodium Photofrin Details
July 25, 2003 None ADVATE Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method (rAHF-PFM) Details
July 24, 2003 etanercept Enbrel Details
July 18, 2003 None PLAC Details
July 9, 2003 None West Nile Virus IgM Capture ELISA Details
July 7, 2003 None Medtronic MiniMed Paradigm insulin pump with a Becton Dickinson glucose monitor Details
June 25, 2003 pravastatin sodium/buffered aspirin Pravigard PAC Details
June 20, 2003 atropine autoinjector Atropen Details
June 20, 2003 omalizumab Xolair Details
June 20, 2003 atazanavir sulfate Reyataz Details
June 17, 2003 Influenza virus vaccine live, intranasal FluMist Details
May 20, 2003 imatinib mesylate Gleevec Details
May 16, 2003 none Platelia Aspergillus EIA Details
May 15, 2003 none Biotronik's implantable cardioverter defibrillator Details
May 13, 2003 bortezomib Velcade Details
May 5, 2003 gefitinib Iressa Details
May 1, 2003 none NIOX Nitric Oxide Test System Details

NOTE: Click on the Details 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.