New and Generic Drug Approvals
November 5, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission 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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