New and Generic Drug Approvals
September 16, 2014
September 16, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Ambisome | amphotericin b | Injectable, Liposomal;Injection | Astellas | Manufacturing Change or Addition |
| Complera | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | Tablet;Oral | Gilead Sciences Inc | Labeling Revision |
| Fortical | calcitonin salmon recombinant | Spray, Metered;Nasal | Upsher Smith | Manufacturing Change or Addition |
| Movantik | naloxegol | Tablet, Tablet;Oral | Astrazeneca Pharms | Approval |
| Tegretol | carbamazepine | Tablet;Oral | Novartis | Labeling Revision |
| Tegretol | carbamazepine | Tablet, Chewable;Oral | Novartis | Labeling Revision |
| Tegretol | carbamazepine | Suspension;Oral | Novartis | Labeling Revision |
| Tegretol-Xr | carbamazepine | Tablet, Extended Release;Oral | Novartis | Labeling Revision |
| Tobramycin Sulfate | tobramycin sulfate | Injectable;Injection | Akorn | Approval |
| Tobramycin Sulfate | tobramycin sulfate | Injectable;Injection | Xellia Pharms Aps | Approval |
| Varithena | polidocanol | Solution;Intravenous | Provensis | Manufacturing Change or Addition |
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