New and Generic Drug Approvals
October 17, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Adrenaclick | epinephrine | Injectable;Intramuscular, Subcutaneous | Amedra Pharms | Manufacturing Change or Addition |
| Aubagio | teriflunomide | Tablet;Oral | Sanofi Aventis Us | Efficacy Supplement with Clinical Data to Support |
| Combivent Respimat | albuterol sulfate; ipratropium bromide | Spray, Metered;Inhalation | Boehringer Ingelheim | Labeling Revision |
| Embeda | morphine sulfate; naltrexone hydrochloride | Capsule, Extended Release;Oral | Alpharma Pharms | Efficacy Supplement with Clinical Data to Support |
| Exidine | chlorhexidine gluconate | Solution;Topical | Xttrium | Labeling Revision |
| Sirturo | bedaquiline fumarate | Tablet;Oral | Janssen Therap | Labeling Revision |
| Twinject 0.15 | epinephrine | Injectable;Intramuscular, Subcutaneous | Amedra Pharms | Manufacturing Change or Addition |
| Twinject 0.3 | epinephrine | Injectable;Intramuscular, Subcutaneous | Amedra Pharms | Manufacturing Change or Addition |
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