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CDER New June 23, 2015

FDA (U.S. Food and Drug Administration)

What's New on the FDA Drugs Site

June 22, 2015

New and Generic Drug Approvals

June 19, 2015

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Amphadase hyaluronidase Injectable;Injection Amphastar Pharm Manufacturing Change or Addition
Azithromycin azithromycin Injectable;Injection Aurobindo Pharma Ltd Approval
Capoten captopril Tablet;Oral Par Pharm Labeling Revision
Centany mupirocin Ointment;Topical Perrigo New York Labeling Revision
Fosamax alendronate sodium Tablet;Oral Merck and Co Inc Manufacturing Change or Addition
Fuzeon enfuvirtide Injectable;Subcutaneous Roche Manufacturing Change or Addition
Fycompa perampanel Tablet;Oral Eisai Inc Efficacy Supplement with Clinical Data to Support
Hemabate carboprost tromethamine Injectable;Injection Pharmacia and Upjohn Manufacturing Change or Addition
Keytruda pembrolizumab Powder, For Injection Solution, Lyophilized Powder Merck Sharp Dohme Labeling Revision
Levofloxacin levofloxacin Tablet;Oral Jubilant Generics Approval
Magnesium Sulfate magnesium sulfate Solution;Intramuscular, Intravenous Fresenius Kabi Usa Manufacturing Change or Addition
Obredon guaifenesin; hydrocodone bitartrate Solution;Oral Sovereign Pharms Manufacturing Change or Addition
Olysio simeprevir sodium Capsule;Oral Janssen Prods Manufacturing Change or Addition
Palonosetron Hydrochloride palonosetron hydrochloride Injectable;Injection Sandoz Inc Tentative Approval
Viekira Pak (Copackaged) dasabuvir sodium ; ombitasvir; paritaprevir; ritonavir Tablet, Tablet;Oral Abbvie Inc Manufacturing Change or Addition
Vimovo esomeprazole magnesium; naproxen Tablet, Delayed Release;Oral Horizon Pharma Labeling Revision
Xeljanz tofacitinib citrate Tablet;Oral Pf Prism Cv Labeling Revision
Zonegran zonisamide Capsule;Oral Eisai Inc Labeling Revision


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