New and Generic Drug Approvals

March 25, 2014

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Acephen	acetaminophen	Suppository;Rectal	G and W Labs	Labeling Revision
Adrenaclick	epinephrine	Injectable;Intramuscular, Subcutaneous	Amedra Pharms	Manufacturing Change or Addition
Emtriva	emtricitabine	Capsule;Oral	Gilead	Manufacturing Change or Addition
Estrogel	estradiol	Gel, Metered;Transdermal	Ascend	Labeling Revision
Estrogel	estradiol	Gel;Topical	Ascend	Labeling Revision
Femhrt	ethinyl estradiol; norethindrone acetate	Tablet;Oral	Warner Chilcott Llc	Manufacturing Change or Addition
Firmagon	degarelix acetate	Powder;Subcutaneous	Ferring	Manufacturing Change or Addition
Fludarabine Phosphate	fludarabine phosphate	Injectable;Injection	Sandoz	Manufacturing Change or Addition
Incivek	telaprevir	Tablet;Oral	Vertex Pharms	Manufacturing Change or Addition
Metro I.V. In Plastic Container	metronidazole	Injectable;Injection	B Braun	Manufacturing Change or Addition
Synarel	nafarelin acetate	Spray, Metered;Nasal	Gd Searle Llc	Manufacturing Change or Addition
Twinject 0.15	epinephrine	Injectable;Intramuscular, Subcutaneous	Amedra Pharms	Manufacturing Change or Addition
Twinject 0.3	epinephrine	Injectable;Intramuscular, Subcutaneous	Amedra Pharms	Manufacturing Change or Addition
Versacloz	clozapine	Suspension;Oral	Jazz Pharms Iii	Manufacturing Change or Addition
Viagra	sildenafil citrate	Tablet;Oral	Pfizer Ireland	Manufacturing Change or Addition
Zenpep	pancrelipase (amylase;lipase;protease)	Capsule, Delayed Release;Oral	Aptalis Pharma Us	Manufacturing Change or Addition