CDER New November 13, 2013

What's New on the FDA Drugs Site

November 12, 2013

• Current Drug Shortages Index (updated)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA approves Aptiom to treat seizures in adults
• FDA approves first generic versions of Aciphex delayed-release tablets to treat GERD
• National Drug Code Directory
• Spanish FDA Drug Safety Communication: Iclusig: Suspensión de ventas y mercadeo de Iclusig (ponatinib): Instrucciones para profesionales de la salud sobre cómo obtener acceso de emergencia a Iclusig para los pacientes que responden a él

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New and Generic Drug Approvals

November 8, 2013

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Aczone	dapsone	Gel;Topical	Allergan	Labeling Revision
Amyvid	florbetapir f-18	Solution;Intravenous	Avid Radiopharms Inc	Manufacturing Change or Addition
Aptiom	eslicarbazepine acetate	Tablet;Oral	Sunovion Pharms Inc	Approval
Atripla	efavirenz; emtricitabine; tenofovir disoproxil fumarate	Tablet;Oral	Gilead	Manufacturing Change or Addition
Cleviprex	clevidipine	Emulsion;Intravenous	Medicines Co	Manufacturing Change or Addition
Complera	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	Tablet;Oral	Gilead Sciences Inc	Manufacturing Change or Addition
Demser	metyrosine	Capsule;Oral	Aton Pharma Vpna	Manufacturing Change or Addition
Emtriva	emtricitabine	Capsule;Oral	Gilead	Manufacturing Change or Addition
Emtriva	emtricitabine	Solution; Oral	Gilead	Manufacturing Change or Addition
Emtriva	emtricitabine	Solution;Oral	Gilead	Manufacturing Change or Addition
Epi E Z Pen Jr	epinephrine	Injectable;Intramuscular	Mylan Speclt	Manufacturing Change or Addition
Epipen	epinephrine	Injectable;Im-Sc	Mylan Speclt	Manufacturing Change or Addition
Epipen E Z Pen	epinephrine	Injectable;Intramuscular	Mylan Speclt	Manufacturing Change or Addition
Epipen Jr.	epinephrine	Injectable;Im-Sc	Mylan Speclt	Manufacturing Change or Addition
Felodipine	felodipine	Tablet, Extended Release;Oral	Heritage Pharms Inc	Approval
Freamine 8.5%	amino acids	Injectable;Injection	B Braun	Manufacturing Change or Addition
Freamine Hbc 6.9%	amino acids	Injectable;Injection	B Braun	Manufacturing Change or Addition
Freamine Ii 8.5%	amino acids	Injectable;Injection	B Braun	Manufacturing Change or Addition
Freamine Iii 10%	amino acids	Injectable;Injection	B Braun	Manufacturing Change or Addition
Freamine Iii 3% W/ Electrolytes	amino acids; magnesium acetate; phosphoric acid; potassium chloride; sodium acetate; sodium chloride	Injectable;Injection	B Braun	Manufacturing Change or Addition
Freamine Iii 8.5%	amino acids	Injectable;Injection	B Braun	Manufacturing Change or Addition
Freamine Iii 8.5% W/ Electrolytes	amino acids; magnesium acetate; phosphoric acid; potassium acetate; potassium chloride; sodium acetate	Injectable;Injection	B Braun	Manufacturing Change or Addition
Indium In-111 Oxyquinoline	indium in-111 oxyquinoline	Injectable;Injection	Ge Healthcare	Manufacturing Change or Addition
Juvisync	simvastatin; sitagliptin phosphate	Tablet;Oral	Merck Sharp Dohme	Manufacturing Change or Addition
Linzess	linaclotide	Capsule;Oral	Forest Labs Inc	Manufacturing Change or Addition
Lupron Depot	leuprolide acetate	Injectable;Injection	Abbvie Endocrine Inc	Manufacturing Change or Addition
Minirin	desmopressin acetate	Spray, Metered;Nasal	Ferring	Labeling Revision
Nexterone	amiodarone hydrochloride	Injectable;Injection	Baxter Hlthcare	Manufacturing Change or Addition
Rabeprazole Sodium	rabeprazole sodium	Tablet, Delayed Release;Oral	Teva Pharms Usa	Approval
Rabeprazole Sodium	rabeprazole sodium	Tablet, Delayed Release;Oral	Dr Reddys Labs Ltd	Approval
Rabeprazole Sodium	rabeprazole sodium	Tablet, Delayed Release;Oral	Mylan Pharms Inc	Approval
Rabeprazole Sodium	rabeprazole sodium	Tablet, Delayed Release;Oral	Lupin Ltd	Approval
Rabeprazole Sodium	rabeprazole sodium	Tablet, Delayed Release;Oral	Kremers Urban Dev	Approval
Rabeprazole Sodium	rabeprazole sodium	Tablet, Delayed Release;Oral	Torrent Pharms Ltd	Approval
Rapaflo	silodosin	Capsule;Oral	Watson Labs	Manufacturing Change or Addition
Solu-Cortef	hydrocortisone sodium succinate	Injectable;Injection	Pharmacia and Upjohn	Manufacturing Change or Addition
Stribild	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	Tablet;Oral	Gilead Sciences Inc	Manufacturing Change or Addition
Tegretol	carbamazepine	Tablet;Oral	Novartis	Manufacturing Change or Addition
Tegretol	carbamazepine	Tablet, Chewable;Oral	Novartis	Manufacturing Change or Addition
Tegretol	carbamazepine	Suspension;Oral	Novartis	Manufacturing Change or Addition
Terbutaline Sulfate	terbutaline sulfate	Injectable;Injection	United Biomedcl	Approval
Tham	tromethamine	Injectable;Injection	Hospira	Manufacturing Change or Addition
Tham-E	potassium chloride; sodium chloride; tromethamine	Injectable;Injection	Hospira	Manufacturing Change or Addition
Trophamine	amino acids	Injectable;Injection	B Braun	Manufacturing Change or Addition
Trophamine 10%	amino acids	Injectable;Injection	B Braun	Manufacturing Change or Addition
Truvada	emtricitabine; tenofovir disoproxil fumarate	Tablet;Oral	Gilead	Manufacturing Change or Addition
Xeljanz	tofacitinib citrate	Tablet;Oral	Pf Prism Cv	Supplement
Zidovudine	zidovudine	Tablet;Oral	Matrix Labs Ltd	Manufacturing Change or Addition

 

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