USFDA: New and Generic Drug Approvals: 05 NOV 2014

New and Generic Drug Approvals

November 5, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Cerdelga eliglustat tartrate Capsule;Oral Genzyme Corp Manufacturing Change or Addition
Cyramza ramucirumab Injectable;Injection Eli Lilly and Co Efficacy Supplement with Clinical Data to Support
Levoxyl levothyroxine sodium Tablet;Oral King Pharms R and D Manufacturing Change or Addition
Lopid gemfibrozil Capsule;Oral Pfizer Pharms Labeling Revision
Lopid gemfibrozil Tablet;Oral Pfizer Pharms Labeling Revision
Olysio simeprevir sodium Capsule;Oral Janssen Prods Efficacy Supplement with Clinical Data to Support
Pennsaid diclofenac sodium Solution;Topical Mallinckrodt Inc Labeling Revision
Protonix Iv pantoprazole sodium Injectable;Iv (Infusion) Wyeth Pharms Inc Manufacturing Change or Addition
Seasonale ethinyl estradiol; levonorgestrel Tablet;Oral Teva Branded Pharm Manufacturing Change or Addition
Zithromax azithromycin For Suspension;Oral Pfizer Manufacturing Change or Addition

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