New and Generic Drug Approvals

 

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

 

May 13, 2013

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Entacapone	entacapone	Tablet; Oral	Mylan Pharms Inc	Approval
Humira	adalimumab	Syringe	Abbott	Labeling Revision
Humira	adalimumab	Vial	Abbott	Labeling Revision
Minocycline Hydrochloride	minocycline hydrochloride	Capsule; Oral	Caraco	Approval
Opana ER	oxymorphone hydrochloride	Tablet, Extended Release; Oral	Endo Pharms	Manufacturing Change or Addition
Prepopik	citric acid; magnesium oxide; sodium picosulfate	For Solution; Oral	Ferring Pharms AS	Manufacturing Change or Addition
Ultra-Technekow FM	technetium tc-99m sodium pertechnetate generator	Solution; Injection, Oral	Mallinckrodt	Manufacturing Change or Addition

 

May 11, 2013

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Tasmar	tolcapone	Tablet; Oral	Valeant Pharms Llc	Labeling Revision

 

May 10, 2013

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Besivance	besifloxacin hydrochloride	Suspension/Drops; Ophthalmic	Bausch and Lomb	Manufacturing Change or Addition
Breo Ellipta	fluticasone furoate; vilanterol trifenatate	Powder; Inhalation	Glaxo Grp Ltd	Approval
Complera	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	Tablet; Oral	Gilead Sciences Inc	Manufacturing Change or Addition
Conray	iothalamate meglumine	Injectable; Injection	Mallinckrodt	Manufacturing Change or Addition
Conray 30	iothalamate meglumine	Injectable; Injection	Mallinckrodt	Manufacturing Change or Addition
Conray 43	iothalamate meglumine	Injectable; Injection	Mallinckrodt	Manufacturing Change or Addition
Cyklokapron	tranexamic acid	Injectable; Injection	Pharmacia and Upjohn	Labeling Revision
Cysto-Conray	iothalamate meglumine	Solution; Intravesical, Ureteral	Mallinckrodt	Manufacturing Change or Addition
Cysto-Conray Ii	iothalamate meglumine	Solution; Intravesical	Mallinckrodt	Manufacturing Change or Addition
Humalog	insulin lispro recombinant	Injectable; Injection	Lilly	Manufacturing Change or Addition
Humalog Kwikpen	insulin lispro recombinant	Injectable; Injection	Lilly	Manufacturing Change or Addition
Humalog Mix 75/25	insulin lispro protamine recombinant; insulin lispro recombinant	Injectable; Injection	Lilly	Manufacturing Change or Addition
Humalog Mix 75/25 Kwikpen	insulin lispro protamine recombinant; insulin lispro recombinant	Injectable; Injection	Lilly	Manufacturing Change or Addition
Humalog Mix 75/25 Pen	insulin lispro protamine recombinant; insulin lispro recombinant	Injectable; Injection	Lilly	Manufacturing Change or Addition
Humalog Pen	insulin lispro recombinant	Injectable; Injection	Lilly	Manufacturing Change or Addition
Humulin 70/30	insulin recombinant human; insulin susp isophane recombinant human	Injectable; Injection	Lilly	Manufacturing Change or Addition
Humulin 70/30 Pen	insulin recombinant human; insulin susp isophane recombinant human	Injectable; Injection	Lilly	Manufacturing Change or Addition
Humulin N	insulin susp isophane recombinant human	Injectable; Injection	Lilly	Manufacturing Change or Addition
Humulin R	insulin recombinant human	Injectable; Injection	Lilly	Manufacturing Change or Addition
Humulin R Pen	insulin recombinant human	Injectable; Injection	Lilly	Manufacturing Change or Addition
Hydrocodone Bitartrate and Acetaminophen	acetaminophen; hydrocodone bitartrate	Solution; Oral	Pai	Approval
Md-76r	diatrizoate meglumine; diatrizoate sodium	Injectable; Injection	Mallinckrodt	Manufacturing Change or Addition
Mefoxin	cefoxitin sodium	Injectable; Injection	Mylan Institutional	Labeling Revision
Nymalize	nimodipine	Solution; Oral	Arbor Pharms Inc	Approval
Ultra-Technekow Fm	technetium tc-99m sodium pertechnetate generator	Solution; Injection, Oral	Mallinckrodt	Manufacturing Change or Addition

 

May 9, 2013

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Codeine Sulfate	codeine sulfate	Solution; Oral	Roxane	Labeling Revision
Daytrana	methylphenidate	Film, Extended Release; Transdermal	Noven Pharms Inc	Manufacturing Change or Addition
Diclofenac Sodium and Misoprostol	diclofenac sodium; misoprostol	Tablet, Delayed Release; Oral	Sandoz	Approval
Fioricet W/ Codeine	acetaminophen; butalbital; caffeine; codeine phosphate	Capsule; Oral	Watson Labs Inc	Labeling Revision
Fiorinal W/Codeine	aspirin; butalbital; caffeine; codeine phosphate	Capsule; Oral	Watson Labs Inc	Labeling Revision
Ilaris	canakinumab	Injectable; Subcutaneous	Novartis Pharms	Efficacy Supplement with Clinical Data to Support
Indocin	indomethacin	Suspension; Oral	Iroko Pharms	Manufacturing Change or Addition
Phenergan Vc W/ Codeine	codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride	Syrup; Oral	Ani Pharms	Labeling Revision
Phenergan W/ Codeine	codeine phosphate; promethazine hydrochloride	Syrup; Oral	Ani Pharms	Labeling Revision
Rituxan	rituximab	Vial	Genentech	Labeling Revision
Soma Compound W/ Codeine	aspirin; carisoprodol; codeine phosphate	Tablet; Oral	Meda Pharms	Labeling Revision
Synalgos-Dc	aspirin; caffeine; dihydrocodeine bitartrate	Capsule; Oral	Caraco	Labeling Revision
Veregen	sinecatechins	Ointment; Topical	Medigene Ag	Manufacturing Change or Addition

 

May 8, 2013

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Erivedge	vismodegib	Capsule; Oral	Genentech	Manufacturing Change or Addition
Flector	diclofenac epolamine	Patch; Topical	Inst Biochem	Manufacturing Change or Addition
Glycine 1.5% In Plastic Container	glycine	Solution; Irrigation	B Braun	Manufacturing Change or Addition
Gris-Peg	griseofulvin, ultramicrosize	Tablet; Oral	Pedinol	Manufacturing Change or Addition
Guanfacine Hydrochloride	guanfacine hydrochloride	Tablet, Extended Release; Oral	Twi Pharms Inc	Tentative Approval
Incivek	telaprevir	Tablet; Oral	Vertex Pharms	Manufacturing Change or Addition
Lo Loestrin Fe	ethinyl estradiol	Tablet; Oral	Warner Chilcott Llc	Manufacturing Change or Addition
Lo Loestrin Fe	ethinyl estradiol; norethindrone acetate	Tablet; Oral	Warner Chilcott Llc	Manufacturing Change or Addition
Lo Loestrin Fe	ferrous fumarate	Tablet; Oral	Warner Chilcott Llc	Manufacturing Change or Addition
Loprox	ciclopirox	Shampoo; Topical	Medicis	Labeling Revision
Physiolyte In Plastic Container	magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate	Solution; Irrigation	B Braun	Manufacturing Change or Addition
Qvar 40	beclomethasone dipropionate	Aerosol, Metered; Inhalation	Teva Branded Pharm	Manufacturing Change or Addition
Qvar 80	beclomethasone dipropionate	Aerosol, Metered; Inhalation	Teva Branded Pharm	Manufacturing Change or Addition
Sodium Chloride 0.9% In Plastic Container	sodium chloride	Solution; Irrigation	B Braun	Manufacturing Change or Addition
Sorbitol 3.3% In Plastic Container	sorbitol	Solution; Irrigation	B Braun	Manufacturing Change or Addition
Sterile Water In Plastic Container	sterile water for irrigation	Liquid; Irrigation	B Braun	Manufacturing Change or Addition
Triamcinolone Acetonide	triamcinolone acetonide	Lotion; Topical	Versapharm Inc	Approval
Wc3040	norethindrone acetate; ethinyl estradiol; ferrous fumarate	Tablet, Chewable; Oral	Warner Chilcott Llc	Approval

 

May 7, 2013

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Cytoxan	cyclophosphamide	Tablet; Oral	Baxter Hlthcare	Labeling Revision
Cytoxan	cyclophosphamide	Injectable; Injection	Baxter Hlthcare	Labeling Revision
Cytoxan (Lyophilized)	cyclophosphamide	Injectable; Injection	Baxter Hlthcare	Labeling Revision
Dyna-Hex	chlorhexidine gluconate	Solution; Topical	Xttrium	Labeling Revision
Gemcitabine Hydrochloride	gemcitabine hydrochloride	Injectable; Injection	Sagent Pharms	Approval
Gemcitabine Hydrochloride	gemcitabine hydrochloride	Injectable; Injection	Pharmaforce	Approval
Gemcitabine Hydrochloride	gemcitabine hydrochloride	Injectable; Injection	Jiangsu Hansoh Pharm	Approval
Gemcitabine Hydrochloride	gemcitabine hydrochloride	Injectable; Injection	Dr Reddys Labs Ltd	Approval
Gemzar	gemcitabine hydrochloride	Injectable; Injection	Lilly	Labeling Revision
Lyophilized Cytoxan	cyclophosphamide	Injectable; Injection	Baxter Hlthcare	Labeling Revision
Thyrogen	thyrotropin alfa	Injectable; Injection	Genzyme	Manufacturing Change or Addition
Zoledronic Acid	zoledronic acid	Injectable; Iv (Infusion)	Pharms	Approval

 

May 6, 2013

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Allopurinol	allopurinol	Tablet; Oral	Accord Hlthcare	Approval
Amlodipine; Valsartan; Hydrochlorothiazide	amlodipine; valsartan; hydrochlorothiazide	Tablet; Oral	Lupin Ltd	Tentative Approval
Avinza	morphine sulfate	Capsule, Extended Release; Oral	King Pfizer	Labeling Revision
Dacogen	decitabine	Injectable; Intravenous	Eisai Inc	Manufacturing Change or Addition
Haldol	haloperidol lactate	Injectable; Injection	Janssen Pharms	Labeling Revision
Haldol	haloperidol decanoate	Injectable; Injection	Janssen Pharms	Labeling Revision
Metadate Cd	methylphenidate hydrochloride	Capsule, Extended Release; Oral	Ucb Inc	Labeling Revision
Optimark	gadoversetamide	Injectable; Injection	Mallinckrodt	Manufacturing Change or Addition
Ritalin La	methylphenidate hydrochloride	Capsule, Extended Release; Oral	Novartis	Labeling Revision
Simponi	golimumab	Injectable; Injection	Centocor Ortho Biotech Inc	Labeling Revision
Tribenzor	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	Tablet; Oral	Daiichi Sankyo	Manufacturing Change or Addition
Vidaza	azacitidine	Injectable; Iv-Sc	Celgene	Manufacturing Change or Addition