New and Generic Drug Approvals

Visit Drugs@FDA to Search Drug Approval Reports by Month

We have changed the format of this page. You will now find approvals listed under the date of the action, rather than the date we added the information to the website.

 

May 18, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Butoconazole Nitrate	butoconazole nitrate	Cream; Vaginal	Perrigo Israel	Approval
Epzicom	abacavir sulfate; lamivudine	Tablet; Oral	Viiv Hlthcare	Labeling Revision
Lansoprazole	lansoprazole	Capsule, Delayed Rel Pellets; Oral	Dr Reddys Labs Ltd	Approval
Lansoprazole	lansoprazole	Capsule, Delayed Rel Pellets; Oral	Perrigo R and D	Approval
Lansoprazole	lansoprazole	Capsule, Delayed Rel Pellets; Oral	Wockhardt Ltd	Approval
Levemir	insulin detemir recombinant	Injectable; Subcutaneous	Novo Nordisk Inc	Efficacy Supplement with Clinical Data to Support
Trizivir	abacavir sulfate; lamivudine; zidovudine	Tablet; Oral	Viiv Hlthcare	Labeling Revision
Ziagen	abacavir sulfate	Tablet; Oral	Viiv Hlthcare	Labeling Revision
Ziagen	abacavir sulfate	Solution; Oral	Viiv Hlthcare	Labeling Revision

 

May 17, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Actoplus Met	metformin hydrochloride; pioglitazone hydrochloride	Tablet; Oral	Takeda Global	Efficacy Supplement with Clinical Data to Support
Actoplus Met	metformin hydrochloride; pioglitazone hydrochloride	Tablet; Oral	Takeda Global	Labeling Revision
Actoplus Met Xr	metformin hydrochloride; pioglitazone hydrochloride	Tablet, Extended Release; Oral	Takeda Global	Labeling Revision
Actos	pioglitazone hydrochloride	Tablet; Oral	Takeda Pharms Usa	Labeling Revision
Avagard	alcohol; chlorhexidine gluconate	Solution; Topical	3m	Labeling Revision
Chg Scrub	chlorhexidine gluconate	Solution; Topical	Ecolab	Labeling Revision
Chlorascrub Maxi Swabstick	chlorhexidine gluconate; isopropyl alcohol	Swab; Topical	Prof Dspls	Labeling Revision
Chlorascrub Swab	chlorhexidine gluconate; isopropyl alcohol	Swab; Topical	Prof Dspls	Labeling Revision
Chlorascrub Swabstick	chlorhexidine gluconate; isopropyl alcohol	Swab; Topical	Prof Dspls	Labeling Revision
Cida-Stat	chlorhexidine gluconate	Solution; Topical	Ecolab	Labeling Revision
Clopidogrel Bisulfate	clopidogrel bisulfate	Tablet; Oral	Apotex Inc	Approval
Clopidogrel Bisulfate	clopidogrel bisulfate	Tablet; Oral	Teva	Approval
Clopidogrel Bisulfate	clopidogrel bisulfate	Tablet; Oral	Mylan Pharms Inc	Approval
Clopidogrel Bisulfate	clopidogrel bisulfate	Tablet; Oral	Roxane	Approval
Clopidogrel Bisulfate	clopidogrel bisulfate	Tablet; Oral	Sun Pharma Global	Approval
Clopidogrel Bisulfate	clopidogrel bisulfate	Tablet; Oral	Aurobindo Pharma Ltd	Approval
Clopidogrel Bisulfate	clopidogrel bisulfate	Tablet; Oral	Teva Pharms	Approval
Clopidogrel Bisulfate	clopidogrel bisulfate	Tablet; Oral	Torrent Pharms Ltd	Approval
Clopidogrel Bisulfate	clopidogrel bisulfate	Tablet; Oral	Dr Reddys Labs Ltd	Approval
Clopidogrel Bisulfate	clopidogrel bisulfate	Tablet; Oral	Gate Pharms	Approval
Duetact	glimepiride; pioglitazone hydrochloride	Tablet; Oral	Takeda Global	Labeling Revision
Lotensin	benazepril hydrochloride	Tablet; Oral	Novartis	Labeling Revision
Pertzye	pancrelipase	Capsule, Delayed Release; Oral	Digestive Care, Inc	Approval
Ropinirole Hydrochloride	ropinirole hydrochloride	Tablet, Extended Release; Oral	Actavis	Approval

 

May 16, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Atomoxetine Hydrochloride	atomoxetine hydrochloride	Capsule; Oral	Apotex Inc	Tentative Approval
Kaletra	lopinavir; ritonavir	Solution; Oral	Abbott	Labeling Revision
Kaletra	lopinavir; ritonavir	Tablet; Oral	Abbott	Labeling Revision

 

May 15, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Lamivudine and Zidovudine	lamivudine; zidovudine	Tablet; Oral	Lupin Ltd	Approval
Lamivudine and Zidovudine	lamivudine; zidovudine	Tablet; Oral	Aurobindo Pharma Ltd	Approval

 

May 11, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Anastrozole	anastrozole	Tablet; Oral	Apotex Inc	Approval
Cetirizine Hydrochloride	cetirizine hydrochloride	Syrup; Oral	Silarx	Approval
Fabior	tazarotene	Foam; Topical	Stiefel Labs Inc	Approval
Morphine Sulfate	morphine sulfate	Tablet, Extended Release; Oral	Ranbaxy Labs Ltd	Approval
Protonix	pantoprazole sodium	Tablet, Delayed Release; Oral	Wyeth Pharms Inc	Labeling Revision
Protonix	pantoprazole sodium	For Suspension, Delayed Release; Oral	Wyeth Pharms Inc	Labeling Revision
Zosyn	piperacillin sodium; tazobactam sodium	Injectable; Injection	Wyeth Pharms Inc	Labeling Revision
Zosyn In Plastic Container	piperacillin sodium; tazobactam sodium	Injectable; Injection	Wyeth Pharms Inc	Labeling Revision

  

May 10, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Carbidopa, Levodopa and Entacapone	carbidopa; entacapone; levodopa	Tablet; Oral	Sun Pharma Global	Approval
Prolia	denosumab	Injectable; Subcutaneous	Amgen	Labeling Revision
Protonix Iv	pantoprazole sodium	Injectable; Iv (Infusion)	Wyeth Pharms Inc	Labeling Revision
Xgeva	denosumab	Injectable; Subcutaneous	Amgen	Labeling Revision
Xolegel	ketoconazole	Gel; Topical	Aqua Pharms	Labeling Revision

 

May 9, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Acetazolamide Sodium	acetazolamide sodium	Injectable; Injection	Sagent Strides	Approval
Gilenya	fingolimod	Capsule; Oral	Novartis	Labeling Revision
Revlimid	lenalidomide	Capsule; Oral	Celgene	Labeling Revision

 

May 8, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Aciphex	rabeprazole sodium	Tablet, Delayed Release; Oral	Eisai Inc	Labeling Revision

 

May 4, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Lamotrigine	lamotrigine	Tablet; Oral	Glenmark Generics	Approval

 

May 3, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Avastin	bevacizumab	Vial; Intravenous	Genentech	Supplement
Biaxin	clarithromycin	Tablet; Oral	Abbott	Labeling Revision
Biaxin	clarithromycin	For Suspension; Oral	Abbott	Labeling Revision
Biaxin Xl	clarithromycin	Tablet, Extended Release; Oral	Abbott	Labeling Revision
Dexilant	dexlansoprazole	Capsule, Delayed Release; Oral	Takeda Pharms	Labeling Revision
Escitalopram Oxalate	escitalopram oxalate	Solution; Oral	Taro	Approval
Imodium A-D	loperamide hydrochloride	Tablet; Oral	Mcneil Cons	Labeling Revision
Imodium Multi-Symptom Relief	loperamide hydrochloride; simethicone	Tablet; Oral	Mcneil Cons	Labeling Revision
Prevacid	lansoprazole	Capsule, Delayed Rel Pellets; Oral	Takeda Pharms Usa	Labeling Revision
Prevacid	lansoprazole	Tablet, Delayed Release, Orally Disintegrating; Oral	Takeda Pharms Usa	Labeling Revision
Teflaro	ceftaroline fosamil	Powder; Iv (Infusion)	Cerexa	Manufacturing Change or Addition
Vardenafil Hydrochloride	vardenafil hydrochloride	Tablet; Oral	Teva Pharms	Approval
Zaditor	ketotifen fumarate	Solution/Drops; Ophthalmic	Alcon Pharma	Labeling Revision
Zarontin	ethosuximide	Capsule; Oral	Parke Davis	Labeling Revision

 

May 2, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Effexor	venlafaxine hydrochloride	Tablet; Oral	Wyeth Pharms Inc	Labeling Revision
Effexor Xr	venlafaxine hydrochloride	Capsule, Extended Release; Oral	Wyeth Pharms Inc	Labeling Revision
Stelara	ustekinumab	Injectable; Injection	Centocor Ortho Biotech Inc	Supplement
Ultravist (Pharmacy Bulk)	iopromide	Injectable; Injection	Bayer Hlthcare	Labeling Revision
Ultravist 150	iopromide	Injectable; Injection	Bayer Hlthcare	Labeling Revision
Ultravist 240	iopromide	Injectable; Injection	Bayer Hlthcare	Labeling Revision
Ultravist 300	iopromide	Injectable; Injection	Bayer Hlthcare	Labeling Revision
Ultravist 300 In Plastic Container	iopromide	Injectable; Injection	Bayer Hlthcare	Labeling Revision
Ultravist 370	iopromide	Injectable; Injection	Bayer Hlthcare	Labeling Revision
Venlafaxine Hydrochloride	venlafaxine hydrochloride	Tablet, Extended Release; Oral	Osmotica Pharm	Labeling Revision
Zestoretic	hydrochlorothiazide; lisinopril	Tablet; Oral	Astrazeneca	Labeling Revision

 

May 1, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Amevive	alefacept	Vial	Astellas	Supplement
Dymista	azelastine hydrochloride; fluticasone proprionate	Spray; Nasal	Meda Pharms	Approval
Elelyso	taliglucerase alfa	Injectable; Injection	Protalix Ltd	Approval
Gabapentin	gabapentin	Solution; Oral	Kiel	Approval
Memantine Hydrochloride	memantine hydrochloride	Tablet; Oral	Apotex Inc	Tentative Approval
Tasigna	nilotinib hydrochloride monohydrate	Capsule; Oral	Novartis	Labeling Revision
Testosterone Cypionate	testosterone cypionate	Injectable; Injection	Hikma Farmaceutica	Approval

 

April 30, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Cancidas	caspofungin acetate	Injectable; Iv (Infusion)	Merck	Approval
Ibandronate Sodium	ibandronate sodium	Tablet; Oral	Dr Reddys Labs Ltd	Approval
Naratriptan	naratriptan hydrochloride	Tablet; Oral	Orchid Hlthcare	Approval
Nevirapine	nevirapine	Tablet, For Suspension; Oral	Cipla Limited	Tentative Approval
Nevirapine	nevirapine	Tablet; Oral	Sciegen Pharm Inc.	Tentative Approval
Pramipexole Dihydrochloride	pramipexole dihydrochloride	Tablet; Oral	Apotex Inc	Approval
Regranex	becaplermin	Gel; Topical	Omj Pharmaceuticals	Approval
Tinidazole	tinidazole	Tablet; Oral	Roxane	Approval
Tinidazole	tinidazole	Tablet; Oral	Novel Labs Inc	Approval

 

April 27, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Atacand	candesartan cilexetil	Tablet; Oral	Astrazeneca	Labeling Revision
Celecoxib	celecoxib	Capsule; Oral	Teva Pharms	Tentative Approval
Levaquin	levofloxacin	Tablet; Oral	Janssen Pharms	Efficacy Supplement with Clinical Data to Support
Levaquin	levofloxacin	Injectable; Injection	Janssen Pharms	Efficacy Supplement with Clinical Data to Support
Levaquin	levofloxacin	Solution; Oral	Janssen Pharms	Efficacy Supplement with Clinical Data to Support
Levaquin In Dextrose 5% In Plastic Container	levofloxacin	Injectable; Injection	Janssen Pharms	Efficacy Supplement with Clinical Data to Support
Levemir	insulin detemir recombinant	Injectable; Subcutaneous	Novo Nordisk Inc	Efficacy Supplement with Clinical Data to Support
Lexiva	fosamprenavir calcium	Tablet; Oral	Viiv Hlthcare	Efficacy Supplement with Clinical Data to Support
Lexiva	fosamprenavir calcium	Suspension; Oral	Viiv Hlthcare	Efficacy Supplement with Clinical Data to Support
Pradaxa	dabigatran etexilate mesylate	Capsule; Oral	Boehringer Ingelheim	Labeling Revision
Prolia	denosumab	Injectable; Subcutaneous	Amgen	Supplement
Stendra	avanafil	Tablet, Tablet; Oral	Vivus	Approval
Xgeva	denosumab	Injectable; Subcutaneous	Amgen	Supplement

 

April 26, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Afinitor	everolimus	Tablet; Oral	Novartis	Labeling Revision
Altoprev	lovastatin	Tablet, Extended Release; Oral	Andrx Labs Llc	Labeling Revision
Androderm	testosterone	Film, Extended Release; Transdermal	Watson Labs	Labeling Revision
Latuda	lurasidone hydrochloride	Tablet; Oral	Sunovion	Efficacy Supplement with Clinical Data to Support
Latuda	lurasidone hydrochloride	Tablet; Oral	Sunovion	Labeling Revision
Ventavis	iloprost	Solution; Inhalation	Actelion Pharms Ltd	Labeling Revision
Votrient	pazopanib hydrochloride	Tablet; Oral	Glaxosmithkline	Labeling Revision
Votrient	pazopanib hydrochloride	Tablet; Oral	Glaxosmithkline	New or Modified Indication
Zortress	everolimus	Tablet; Oral	Novartis	Labeling Revision

 

April 25, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Valturna	aliskiren hemifumarate; valsartan	Tablet; Oral	Novartis	Labeling Revision

 

April 24, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Atorvastatin Calcium	atorvastatin calcium	Tablet; Oral	Apotex Inc	Tentative Approval
Kalbitor	ecallantide	Injectable; Injection	Dyax Corp.	Supplement
Prandimet	metformin hydrochloride; repaglinide	Tablet; Oral	Novo Nordisk Inc	Labeling Revision

 

April 23, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Cefazolin and Dextrose	cefazolin sodium	Injectable; Injection	B Braun	Labeling Revision
Lamisil	terbinafine hydrochloride	Tablet; Oral	Novartis	Labeling Revision
Lamisil	terbinafine hydrochloride	Granule; Oral	Novartis	Labeling Revision
Olanzapine	olanzapine	Tablet; Oral	Dr Reddys Labs Ltd	Approval
Olanzapine	olanzapine	Tablet; Oral	Dr Reddys Labs Ltd	Approval
Olanzapine	olanzapine	Tablet; Oral	Mylan	Approval
Olanzapine	olanzapine	Tablet; Oral	Apotex Inc	Approval
Olanzapine	olanzapine	Tablet; Oral	Sun Pharm Inds	Approval
Olanzapine	olanzapine	Tablet; Oral	Torrent Pharms Ltd	Approval
Olanzapine	olanzapine	Tablet; Oral	Aurobindo Pharma Ltd	Approval
Olanzapine	olanzapine	Tablet; Oral	Orchid Hlthcare	Approval
Prevacid 24 Hr	lansoprazole	Capsule, Delayed Rel Pellets; Oral	Novartis	Labeling Revision