New and Generic Drug Approvals
October 20, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Absorica | isotretinoin | Capsule;Oral | Ranbaxy | Manufacturing Change or Addition |
| Afinitor | everolimus | Tablet;Oral | Novartis | Manufacturing Change or Addition |
| Boniva | ibandronate sodium | Injectable;Intravenous | Roche | Manufacturing Change or Addition |
| Cleocin Phosphate | clindamycin phosphate | Injectable;Injection | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Dutoprol | hydrochlorothiazide; metoprolol succinate | Tablet, Extended Release;Oral | Covis Pharma Sarl | Labeling Revision |
| Nexium Iv | esomeprazole sodium | Injectable;Intravenous | Astrazeneca | Manufacturing Change or Addition |
| Tarka | trandolapril; verapamil hydrochloride | Tablet, Extended Release;Oral | Abbvie | Manufacturing Change or Addition |
| Xiaflex | collagenase clostridium histolyticum | Solution; Injection | Auxilium Pharms | Efficacy Supplement with Clinical Data to Support |
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