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.