New and Generic Drug Approvals
October 15, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Aciphex | rabeprazole sodium | Tablet, Delayed Release;Oral | Eisai Inc | Labeling Revision |
| Aciphex Sprinkle | rabeprazole sodium | Capsule, Delayed Release;Oral | Eisai Inc | Labeling Revision |
| Chantix | varenicline tartrate | Tablet;Oral | Pfizer Inc | Efficacy Supplement with Clinical Data to Support |
| Chantix | varenicline tartrate | Tablet;Oral | Pfizer Inc | Labeling Revision |
| Curosurf | poractant alfa | Suspension;Intratracheal | Chiesi Usa Inc | Manufacturing Change or Addition |
| Duac | benzoyl peroxide; clindamycin phosphate | Gel;Topical | Stiefel | Manufacturing Change or Addition |
| Erivedge | vismodegib | Capsule;Oral | Genentech | Manufacturing Change or Addition |
| Esbriet | pirfenidone | Capsule;Oral | Intermune Inc | Approval |
| Istodax | romidepsin | Powder;Iv (Infusion) | Celgene | Efficacy Supplement with Clinical Data to Support |
| Marqibo Kit | vincristine sulfate | Injectable, Liposomal;Intravenous | Talon Therap | Manufacturing Change or Addition |
| Neuraceq | florbetaben f-18 | Solution;Intravenous | Piramal Imaging | Manufacturing Change or Addition |
| Ofev | nintedanib | Capsule;Oral | Boehringer Ingelheim | Approval |
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