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.

 

 

September 13, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Butalbital, Acetaminophen and Caffeine	acetaminophen; butalbital; caffeine	Tablet; Oral	Lannett Holdings Inc	Approval
Increlex	mecasermin recombinant	Injectable; Subcutaneous	Ipsen Inc	Labeling Revision
Prilosec Otc	omeprazole magnesium	Tablet, Delayed Release; Oral	Astrazeneca	Labeling Revision
Uniretic	hydrochlorothiazide; moexipril hydrochloride	Tablet; Oral	Ucb Inc	Labeling Revision
Vaseretic	enalapril maleate; hydrochlorothiazide	Tablet; Oral	Valeant Intl	Labeling Revision
Vasotec	enalapril maleate	Tablet; Oral	Valeant Intl	Labeling Revision
Voltaren	diclofenac sodium	Solution/Drops; Ophthalmic	Novartis	Labeling Revision

 

September 12, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Aubagio	teriflunomide	Tablet; Oral	Sanofi Aventis Us	Approval
Avapro	irbesartan	Tablet; Oral	Sanofi Aventis Us	Labeling Revision
Choline C 11	choline c 11	Injectable; Injection	Mayo Clinic Mcprf	Approval
Escitalopram Oxalate	escitalopram oxalate	Tablet; Oral	Sti Pharma Llc	Approval
Escitalopram Oxalate	escitalopram oxalate	Tablet; Oral	Jubilant Organosys	Approval
Olanzapine	olanzapine	Tablet, Orally Disintegrating; Oral	Jubilant Organosys	Approval
Tarka	trandolapril; verapamil hydrochloride	Tablet, Extended Release; Oral	Abbott	Labeling Revision
Teveten	eprosartan mesylate	Tablet; Oral	Abbott	Labeling Revision
Teveten Hct	eprosartan mesylate; hydrochlorothiazide	Tablet; Oral	Abbott	Labeling Revision

 

September 11, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Escitalopram Oxalate	escitalopram oxalate	Tablet; Oral	Zydus Pharms Usa Inc	Approval
Escitalopram Oxalate	escitalopram oxalate	Tablet; Oral	Lupin Ltd	Approval
Escitalopram Oxalate	escitalopram oxalate	Tablet; Oral	Invagen Pharms	Approval
Escitalopram Oxalate	escitalopram oxalate	Tablet; Oral	Hikma Pharms	Approval
Escitalopram Oxalate	escitalopram oxalate	Tablet; Oral	Apotex Inc	Approval
Escitalopram Oxalate	escitalopram oxalate	Tablet; Oral	Aurobindo Pharma Ltd	Approval
Escitalopram Oxalate	escitalopram oxalate	Tablet; Oral	Torrent Pharms Ltd	Approval
Escitalopram Oxalate	escitalopram oxalate	Tablet; Oral	Macleods Pharms Ltd	Approval
Escitalopram Oxalate	escitalopram oxalate	Tablet; Oral	Accord Hlthcare	Approval
Gemcitabine Hydrochloride	gemcitabine hydrochloride	Injectable; Injection	Emcure Pharms Ltd	Approval
Mavik	trandolapril	Tablet; Oral	Abbott	Labeling Revision

 

September 10, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Gemcitabine	gemcitabine	Injectable; Injection	Hameln Rds Gmbh	Approval
Omeprazole	omeprazole	Tablet, Delayed Release; Oral	Dexcel Pharma	Approval
Zyrtec Allergy	cetirizine hydrochloride	Tablet; Oral	Mcneil Consumer	Labeling Revision
Zyrtec Hives Relief	cetirizine hydrochloride	Tablet; Oral	Mcneil Consumer	Labeling Revision

 

September 7, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Aggrenox	aspirin; dipyridamole	Capsule, Extended Release; Oral	Boehringer Ingelheim	Labeling Revision
Androgel	testosterone	Gel, Metered; Transdermal	Abbott Labs	Labeling Revision
Clobex	clobetasol propionate	Spray; Topical	Galderma Labs Lp	Labeling Revision
Levofloxacin	levofloxacin	Tablet; Oral	Zydus Pharms Usa Inc	Approval
Multaq	dronedarone hydrochloride	Tablet; Oral	Sanofi Aventis Us	Efficacy Supplement with Clinical Data to Support
Multaq	dronedarone hydrochloride	Tablet; Oral	Sanofi Aventis Us	Labeling Revision
Ozurdex	dexamethasone	Implant; Intravitreal	Allergan	Labeling Revision
Xopenex	levalbuterol hydrochloride	Solution; Inhalation	Sunovion	Labeling Revision

 

September 6, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Bicillin C-R	penicillin g benzathine; penicillin g procaine	Injectable; Injection	King Pharms	Labeling Revision
Bicillin C-R 900/300	penicillin g benzathine; penicillin g procaine	Injectable; Injection	King Pharms	Labeling Revision
Bicillin L-A	penicillin g benzathine	Injectable; Injection	King Pharms	Labeling Revision
Cefepime and Dextrose In Duplex Container	cefepime hydrochloride	Injectable; Injection	B Braun	Labeling Revision
Cefepime In Plastic Container	cefepime hydrochloride	Injectable; Injection	Baxter Hlthcare	Labeling Revision
Leucovorin Calcium Preservative Free	leucovorin calcium	Injectable; Injection	Sagent Pharms	Approval
Leucovorin Calcium Preservative Free	leucovorin calcium	Injectable; Injection	Sagent Pharms	Approval
Maxipime	cefepime hydrochloride	Injectable; Injection	Hospira Inc	Labeling Revision
Tramadol Hydrochloride and Acetaminophen	acetaminophen; tramadol hydrochloride	Tablet; Oral	Zydus Pharms Usa Inc	Approval
Ventolin Hfa	albuterol sulfate	Aerosol, Metered; Inhalation	Glaxosmithkline	Labeling Revision
Xyzal	levocetirizine dihydrochloride	Tablet; Oral	Ucb Inc	Labeling Revision
Xyzal	levocetirizine dihydrochloride	Solution; Oral	Ucb Inc	Labeling Revision

 

September 5, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Amlodipine Besylate and Benazepril Hydrochloride	amlodipine besylate; benazepril hydrochloride	Capsule; Oral	Aurobindo Pharma Ltd	Approval
Declomycin	demeclocycline hydrochloride	Tablet; Oral	Corepharma	Labeling Revision
Trilipix	choline fenofibrate	Capsule, Delayed Release; Oral	Abbott Labs	Labeling Revision
Trilipix	choline fenofibrate	Capsule, Delayed Release; Oral	Abbott Labs	Manufacturing Change or Addition
Ziprasidone Hydrochloride	ziprasidone hydrochloride	Capsule; Oral	Wockhardt Ltd	Approval

 

September 4, 2012

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Aricept	donepezil hydrochloride	Tablet; Oral	Eisai Inc	Labeling Revision
Aricept	donepezil hydrochloride	Tablet; Oral	Eisai Inc	Labeling Revision
Aricept Odt	donepezil hydrochloride	Tablet, Orally Disintegrating; Oral	Eisai Inc	Labeling Revision
Bosulif	bosutinib	Tablet; Oral	Wyeth Pharms Inc	Approval
Children's Advil	ibuprofen	Suspension; Oral	Wyeth Cons	Manufacturing Change or Addition
Children's Advil-Flavored	ibuprofen	Suspension; Oral	Wyeth Cons	Manufacturing Change or Addition
Lovaza	omega-3-acid ethyl esters	Capsule; Oral	Smithkline Beecham	Labeling Revision