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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
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 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.

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 o