New and Generic Drug Approvals

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Adrenaclick	epinephrine	Injectable;Intramuscular, Subcutaneous	Amedra Pharms	Labeling Revision
Byetta	exenatide synthetic	Injectable;Subcutaneous	Astrazeneca Ab	Manufacturing Change or Addition
Chemet	succimer	Capsule;Oral	Recordati Rare	Manufacturing Change or Addition
Clarinex	desloratadine	Tablet;Oral	Merck Sharp Dohme	Labeling Revision
Clarinex	desloratadine	Syrup;Oral	Merck Sharp Dohme	Labeling Revision
Clarinex	desloratadine	Tablet, Orally Disintegrating;Oral	Merck Sharp Dohme	Labeling Revision
Clarinex	desloratadine	Syrup; Oral	Schering	Labeling Revision
Delflex W/ Dextrose 1.5% In Plastic Container	calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate	Solution;Intraperitoneal	Fresenius Medcl	Manufacturing Change or Addition
Delflex W/ Dextrose 1.5% Low Magnesium In Plastic Container	calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate	Solution;Intraperitoneal	Fresenius Medcl	Manufacturing Change or Addition
Delflex W/ Dextrose 1.5% Low Magnesium Low Calcium In Plastic Container	calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate	Solution;Intraperitoneal	Fresenius Medcl	Manufacturing Change or Addition
Delflex W/ Dextrose 2.5% In Plastic Container	calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate	Solution;Intraperitoneal	Fresenius Medcl	Manufacturing Change or Addition
Delflex W/ Dextrose 2.5% Low Magnesium In Plastic Container	calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate	Solution;Intraperitoneal	Fresenius Medcl	Manufacturing Change or Addition
Delflex W/ Dextrose 2.5% Low Magnesium Low Calcium In Plastic Container	calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate	Solution;Intraperitoneal	Fresenius Medcl	Manufacturing Change or Addition
Delflex W/ Dextrose 4.25% In Plastic Container	calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate	Solution;Intraperitoneal	Fresenius Medcl	Manufacturing Change or Addition
Delflex W/ Dextrose 4.25% Low Magnesium In Plastic Container	calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate	Solution;Intraperitoneal	Fresenius Medcl	Manufacturing Change or Addition
Delflex W/ Dextrose 4.25% Low Magnesium Low Calcium In Plastic Container	calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate	Solution;Intraperitoneal	Fresenius Medcl	Manufacturing Change or Addition
Depocyt	cytarabine	Injectable, Liposomal;Injection	Pacira Pharms Inc	Manufacturing Change or Addition
Diovan Hct	hydrochlorothiazide; valsartan	Tablet;Oral	Novartis	Manufacturing Change or Addition
Docetaxel	docetaxel	Injectable;Injection	Sandoz	Labeling Revision
Juxtapid	lomitapide mesylate	Capsule;Oral	Aegerion	Manufacturing Change or Addition
Kuvan	sapropterin dihydrochloride	Tablet;Oral	Biomarin Pharm	Efficacy Supplement with Clinical Data to Support
Memantine Hydrochloride	memantine hydrochloride	Tablet;Oral	Jubilant Life	Tentative Approval
Niacin	niacin	Tablet, Extended Release;Oral	Sun Pharma Global	Approval
Niacin	niacin	Tablet, Extended Release;Oral	Sun Pharma Global	Approval
Norethindrone Acetate;Ethinyl Estradiol;Ferrous Fumarate	norethindrone acetate;ethinyl estradiol;ferrous fumarate	Tablet;Oral	Famy Care Ltd	Approval
Olux	clobetasol propionate	Aerosol, Foam;Topical	Stiefel Labs Inc	Labeling Revision
Omtryg	omega-3 acid ethyl esters a	Capsule;Oral	Trygg Pharma Inc	Approval
Spironolactone	spironolactone	Tablet;Oral	Jubilant Life	Approval
Twinject 0.15	epinephrine	Injectable;Intramuscular, Subcutaneous	Amedra Pharms	Labeling Revision
Twinject 0.3	epinephrine	Injectable;Intramuscular, Subcutaneous	Amedra Pharms	Labeling Revision