New and Generic Drug Approvals

 

May 21, 2013

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Cuvposa	glycopyrrolate	Solution; Oral	Merz Pharms	Labeling Revision
Dopamine Hydrochloride In Dextrose 5% In Plastic Container	dopamine hydrochloride	Injectable; Injection	Baxter Hlthcare	Manufacturing Change or Addition
Lanoxin	digoxin	Tablet; Oral	Covis Pharma	Manufacturing Change or Addition
Methergine	methylergonovine maleate	Injectable; Injection	Us Pharms Holdings I	Manufacturing Change or Addition
Methergine	methylergonovine maleate	Tablet; Oral	Us Pharms Holdings I	Manufacturing Change or Addition
Optimark	gadoversetamide	Injectable; Injection	Mallinckrodt	Labeling Revision
Optimark	gadoversetamide	Injectable; Injection	Mallinckrodt	Labeling Revision
Optimark In Plastic Container	gadoversetamide	Injectable; Injection	Mallinckrodt	Labeling Revision
Razadyne	galantamine hydrobromide	Tablet; Oral	Janssen Pharms	Manufacturing Change or Addition
Razadyne	galantamine hydrobromide	Solution; Oral	Janssen Pharms	Manufacturing Change or Addition
Razadyne Er	galantamine hydrobromide	Capsule, Extended Release; Oral	Janssen Pharms	Manufacturing Change or Addition
Stelara	ustekinumab	Injectable; Injection	Centocor Ortho Biotech Inc	Efficacy Supplement with Clinical Data to Support
Sumatriptan Succinate	sumatriptan succinate	Tablet; Oral	Hikma Pharms	Approval

 

May 20, 2013

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Androgel	testosterone	Gel, Metered; Transdermal	Abbvie	Labeling Revision
Androgel	testosterone	Gel; Transdermal	Abbvie	Labeling Revision
Androgel	testosterone	Gel, Metered; Transdermal	Abbvie	Labeling Revision
Androgel	testosterone	Gel; Transdermal	Abbvie	Labeling Revision
Argatroban In Sodium Chloride	argatroban	Injectable; Iv (Infusion)	Eagle Pharms	Manufacturing Change or Addition
Eldepryl	selegiline hydrochloride	Capsule; Oral	Somerset	Manufacturing Change or Addition
Strattera	atomoxetine hydrochloride	Capsule; Oral	Lilly	Manufacturing Change or Addition

 

May 17, 2013

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Angiomax	bivalirudin	Injectable; Intravenous	Medicines Co	Labeling Revision
Lamivudine; Tenofovir Disoproxil Fumarate	lamivudine; tenofovir disoproxil fumarate	Tablet; Oral	Ranbaxy Labs Ltd	Tentative Approval
Levetiracetam	levetiracetam	Tablet, Extended Release; Oral	Apotex Inc	Tentative Approval
Tasigna	nilotinib hydrochloride monohydrate	Capsule; Oral	Novartis	Labeling Revision
Ultravate	halobetasol propionate	Ointment; Topical	Ranbaxy	Manufacturing Change or Addition

 

May 16, 2013

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Estradiol	estradiol	Film, Extended Release; Transdermal	Novartis	Labeling Revision
Habitrol	nicotine	Film, Extended Release; Transdermal	Novartis	Manufacturing Change or Addition
Inspra	eplerenone	Tablet; Oral	Gd Searle Llc	Labeling Revision
Lanoxin	digoxin	Injectable; Injection	Covis Pharma	Labeling Revision
Lanoxin Pediatric	digoxin	Injectable; Injection	Covis Pharma	Labeling Revision
Lantus	insulin glargine recombinant	Injectable; Injection	Sanofi Aventis Us	Labeling Revision
Letrozole	letrozole	Tablet; Oral	Jiangsu Hengrui Med	Approval
Pegasys	peginterferon alfa-2a	Syringe	Hoffman-La Roche	Labeling Revision
Pegasys	peginterferon alfa-2a	Vial; Subcutaneous	Hoffman-La Roche	Labeling Revision
Rivastigmine Tartrate	rivastigmine tartrate	Capsule; Oral	Apotex Inc	Approval
Tramadol Hydrochloride	tramadol hydrochloride	Tablet; Oral	Accord Hlthcare Inc	Approval
Vivelle-Dot	estradiol	Film, Extended Release; Transdermal	Novartis	Labeling Revision

 

May 15, 2013

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Accolate	zafirlukast	Tablet; Oral	Astrazeneca	Manufacturing Change or Addition
Altoprev	lovastatin	Tablet, Extended Release; Oral	Andrx Labs Llc	Manufacturing Change or Addition
Colcrys	colchicine	Tablet; Oral	Takeda Pharms Usa	Manufacturing Change or Addition
Durezol	difluprednate	Emulsion; Ophthalmic	Alcon Pharms Ltd	Labeling Revision
Infergen	interferon alfacon-1	Vial	Intermune Pharms	Labeling Revision
Kombiglyze Xr	metformin hydrochloride; saxagliptin hydrochloride	Tablet, Extended Release; Oral	Bristol Myers Squibb	Manufacturing Change or Addition
Norditropin	somatropin recombinant	Injectable; Injection	Novo Nordisk Inc	Manufacturing Change or Addition
Norditropin Flexpro	somatropin recombinant	Injectable; Injection	Novo Nordisk Inc	Manufacturing Change or Addition
Norditropin Nordiflex	somatropin recombinant	Injectable; Injection	Novo Nordisk Inc	Manufacturing Change or Addition
Pegintron	peginterferon alfa-2b	Syringe	Schering	Labeling Revision
Pegintron	peginterferon alfa-2b	Vial	Schering	Labeling Revision
Prilosec	omeprazole	Capsule, Delayed Rel Pellets; Oral	Astrazeneca	Labeling Revision
Pulmicort Respules	budesonide	Suspension; Inhalation	Astrazeneca	Manufacturing Change or Addition
Quillivant Xr	methylphenidate hydrochloride	For Suspension, Extended Release; Oral	Nextwave Pharms	Manufacturing Change or Addition
Rocaltrol	calcitriol	Solution; Oral	Validus Pharms	Manufacturing Change or Addition
Simponi	golimumab	Injectable; Injection	Centocor Ortho Biotech Inc	Efficacy Supplement with Clinical Data to Support
Sylatron	peginterferon alfa-2b	Vial	Schering	Labeling Revision
Transderm Scop	scopolamine	Film, Extended Release; Transdermal	Novartis	Manufacturing Change or Addition
Xofigo	radium ra 223 dichloride	Injectable; Injection	Bayer Pharms	Approval
Zolmitriptan	zolmitriptan	Tablet, Orally Disintegrating; Oral	Zydus Pharms Usa Inc	Approval

 

May 14, 2013

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Climara	estradiol	Film, Extended Release; Transdermal	Bayer Hlthcare	Manufacturing Change or Addition
Lupron Depot-Ped	leuprolide acetate	Injectable; Injection	Abbott Endocrine	Labeling Revision
Megace Es	megestrol acetate	Suspension; Oral	Par Pharm	Labeling Revision
Retin-A	tretinoin	Gel; Topical	Valeant Intl	Manufacturing Change or Addition
Ridaura	auranofin	Capsule; Oral	Prometheus Labs	Manufacturing Change or Addition
Tarceva	erlotinib hydrochloride	Tablet; Oral	Osi Pharms	New or Modified Indication
Zolmitriptan	zolmitriptan	Tablet; Oral	Glenmark Generics	Approval
Zolmitriptan	zolmitriptan	Tablet; Oral	Apotex Inc	Approval
Zolmitriptan	zolmitriptan	Tablet, Orally Disintegrating; Oral	Apotex Inc	Approval
Zolmitriptan	zolmitriptan	Tablet, Orally Disintegrating; Oral	Glenmark Generics	Approval
Zolmitriptan	zolmitriptan	Tablet; Oral	Mylan Pharms Inc	Approval