New and Generic Drug Approvals U.S. Food and Drug Administration April-20126

April 7, 2016

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Afrezza	insulin recombinant human	Powder;Inhalation	Sanofi Aventis	Manufacturing Change or Addition
Endometrin	progesterone	Insert;Vaginal	Ferring	Manufacturing Change or Addition
Esmolol Hydrochloride	esmolol hydrochloride	Injectable;Injection	Hq Speciality Pharma	Approval
Gemcitabine Hydrochloride	gemcitabine hydrochloride	Injectable;Injection	Hospira Inc	Manufacturing Change or Addition
Loprox	ciclopirox	Shampoo;Topical	Medicis	Manufacturing Change or Addition
Nicardipine Hydrochloride	nicardipine hydrochloride	Injectable;Injection	Exela Pharma Science	Manufacturing Change or Addition
Starlix	nateglinide	Tablet;Oral	Novartis	Manufacturing Change or Addition
Valstar Preservative Free	valrubicin	Solution;Intravesical	Endo Pharm	Labeling Revision
Vizamyl	flutemetamol f-18	Injectable;Intravenous	Ge Healthcare	Labeling Revision
Xanax Xr	alprazolam	Tablet, Extended Release;Oral	Pharmacia and Upjohn	Manufacturing Change or Addition

April 6, 2016

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Belviq	lorcaserin hydrochloride	Tablet;Oral	Eisai Inc	Manufacturing Change or Addition
Keppra Xr	levetiracetam	Tablet, Extended Release;Oral	Ucb Inc	Labeling Revision
Linzess	linaclotide	Capsule;Oral	Forest Labs Llc	Labeling Revision
Lopid	gemfibrozil	Capsule;Oral	Pfizer Pharms	Labeling Revision
Lopid	gemfibrozil	Tablet;Oral	Pfizer Pharms	Labeling Revision
Orkambi	ivacaftor; lumacaftor	Tablet;Oral	Vertex Pharms Inc	Manufacturing Change or Addition
Rozerem	ramelteon	Tablet;Oral	Takeda Pharms Usa	Manufacturing Change or Addition
Zonegran	zonisamide	Capsule;Oral	Sunovion Pharms Inc	Labeling Revision

April 5, 2016

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Children's Claritin	loratadine	Tablet, Chewable;Oral	Bayer Healthcare Llc	Labeling Revision
Exparel	bupivacaine	Injectable, Liposomal;Injection	Pacira Pharms Inc	Manufacturing Change or Addition
Heparin Sodium 1,000 Units In Sodium Chloride 0.9% In Plastic Container	heparin sodium	Injectable;Injection	Hospira	Labeling Revision
Heparin Sodium 10,000 Units In Sodium Chloride 0.45%	heparin sodium	Injectable;Injection	Hospira	Labeling Revision
Heparin Sodium 10,000 Units In Sodium Chloride 0.9%	heparin sodium	Injectable;Injection	Hospira	Labeling Revision
Heparin Sodium 12,500 Units In Sodium Chloride 0.45% In Plastic Container	heparin sodium	Injectable;Injection	Hospira	Labeling Revision
Heparin Sodium 12,500 Units In Sodium Chloride 0.9%	heparin sodium	Injectable;Injection	Hospira	Labeling Revision
Heparin Sodium 2,000 Units In Sodium Chloride 0.9% In Plastic Container	heparin sodium	Injectable;Injection	Hospira	Labeling Revision
Heparin Sodium 25,000 Units In Sodium Chloride 0.45% In Plastic Container	heparin sodium	Injectable;Injection	Hospira	Labeling Revision
Heparin Sodium 25,000 Units In Sodium Chloride 0.9% In Plastic Container	heparin sodium	Injectable;Injection	Hospira	Labeling Revision
Heparin Sodium 5,000 Units In Sodium Chloride 0.45%	heparin sodium	Injectable;Injection	Hospira	Labeling Revision
Heparin Sodium 5,000 Units In Sodium Chloride 0.9%	heparin sodium	Injectable;Injection	Hospira	Labeling Revision
Humulin N	insulin susp isophane recombinant human	Injectable;Injection	Lilly	Manufacturing Change or Addition
Imodium A-D	loperamide hydrochloride	Solution;Oral	J and J Consumer Inc	Labeling Revision
Imodium A-D	loperamide hydrochloride	Suspension;Oral	J and J Consumer Inc	Labeling Revision
Inflectra	infliximab-dyyb	Injectable;Injection	Celltrion Inc	Approval
Inomax	nitric oxide	Gas;Inhalation	Mallinckrodt Hosp	Labeling Revision
Kazano	alogliptin benzoate; metformin hydrochloride	Tablet;Oral	Takeda Pharms Usa	Efficacy Supplement with Clinical Data to Support
Kombiglyze Xr	metformin hydrochloride; saxagliptin hydrochloride	Tablet, Extended Release;Oral	Astrazeneca Ab	Efficacy Supplement with Clinical Data to Support
Lonsurf	tipiracil hydrochloride; trifluridine	Tablet;Oral	Taiho Oncology	Manufacturing Change or Addition
Nesina	alogliptin benzoate	Tablet;Oral	Takeda Pharms Usa	Efficacy Supplement with Clinical Data to Support
Onglyza	saxagliptin hydrochloride	Tablet;Oral	Astrazeneca Ab	Efficacy Supplement with Clinical Data to Support
Oseni	alogliptin benzoate; pioglitazone hydrochloride	Tablet;Oral	Takeda Pharms Usa	Efficacy Supplement with Clinical Data to Support

April 4, 2016

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Aciphex	rabeprazole sodium	Tablet, Delayed Release;Oral	Eisai Inc	Labeling Revision
Aciphex Sprinkle	rabeprazole sodium	Capsule, Delayed Release;Oral	Eisai Inc	Labeling Revision
Bosulif	bosutinib monohydrate	Tablet;Oral	Wyeth Pharms Inc	Labeling Revision
Habitrol	nicotine	Film, Extended Release; Transdermal	Dr Reddys Labs Inc	Manufacturing Change or Addition
Habitrol	nicotine	Film, Extended Release;Transdermal	Dr Reddys Labs Inc	Manufacturing Change or Addition
Vagifem	estradiol	Tablet;Vaginal	Novo Nordisk Inc	Manufacturing Change or Addition
Varubi	rolapitant hydrochloride	Tablet;Oral	Tesaro Inc	Manufacturing Change or Addition
Zyrtec Allergy	cetirizine hydrochloride	Tablet;Oral	J and J Consumer Inc	Manufacturing Change or Addition
Zyrtec Hives Relief	cetirizine hydrochloride	Tablet;Oral	J and J Consumer Inc	Manufacturing Change or Addition

April 1, 2016

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Hicon	sodium iodide i-131	Solution;Oral	Jubilant Draximage	Manufacturing Change or Addition
Jublia	efinaconazole	Solution;Topical	Dow Pharm	Manufacturing Change or Addition
Rosiglitazone Maleate and Glimepiride	glimepiride; rosiglitazone maleate	Tablet;Oral	Teva Pharms Usa	Approval
Sodium Iodide I-131	sodium iodide i-131	Capsule;Oral	Jubilant Draximage	Manufacturing Change or Addition
Tindamax	tinidazole	Tablet;Oral	Mission Pharma	Manufacturing Change or Addition
Triumeq	abacavir sulfate; dolutegravir sodium; lamivudine	Tablet;Oral	Viiv Hlthcare	Manufacturing Change or Addition

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Page Last Updated: 04/08/2016