New and Generic Drug Approvals
September 10, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Contrave | naltrexone hydrochloride;bupropion hydrochloride | Tablet, Extended Release;Oral | Orexigen Therapeutics Inc | Approval |
| Emsam | selegiline | Film, Extended Release;Transdermal | Somerset | Efficacy Supplement with Clinical Data to Support |
| Emsam | selegiline | Film, Extended Release;Transdermal | Somerset | Labeling Revision |
| Emsam | selegiline | System; Transdermal | Somerset | Approval |
| Famciclovir | famciclovir | Tablet;Oral | Hetero Labs Ltd V | Approval |
| Montelukast Sodium | montelukast sodium | Tablet;Oral | Hetero Drugs Ltd | Approval |
| Mucinex | guaifenesin | Tablet, Extended Release;Oral | Reckitt Benckiser | Manufacturing Change or Addition |
| Oxycodone Hydrochloride | oxycodone hydrochloride | Solution;Oral | Lannett Holdings Inc | Approval |
| Oxytocin | oxytocin | Injectable;Injection | Fresenius Kabi Usa | Manufacturing Change or Addition |
| Pantoprazole Sodium | pantoprazole sodium | Tablet, Delayed Release;Oral | Hetero Labs Ltd V | Approval |
| Xtandi | enzalutamide | Capsule;Oral | Astellas | Efficacy Supplement with Clinical Data to Support |
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