New and Generic Drug Approvals
November 24, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Acanya | benzoyl peroxide; clindamycin phosphate | Gel;Topical | Dow Pharm | Efficacy Supplement with Clinical Data to Support |
| Byetta | exenatide synthetic | Injectable;Subcutaneous | Astrazeneca Ab | Efficacy Supplement with Clinical Data to Support |
| Diclofenac Sodium | diclofenac sodium | Solution;Topical | Paddock Llc | Approval |
| Optimark | gadoversetamide | Injectable;Injection | Mallinckrodt | Labeling Revision |
| Optimark | gadoversetamide | Injectable;Injection | Mallinckrodt | Labeling Revision |
| Optimark In Plastic Container | gadoversetamide | Injectable;Injection | Mallinckrodt | Labeling Revision |
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