New and Generic Drug Approvals
August 27, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Clonazepam | clonazepam | Tablet;Oral | Sun Pharm Inds Inc | Approval |
| Elelyso | taliglucerase alfa | Powder;Iv (Infusion) | Pfizer | Efficacy Supplement with Clinical Data to Support |
| Elelyso | taliglucerase alfa | Powder;Iv (Infusion) | Pfizer | Labeling Revision |
| Ella | ulipristal acetate | Tablet;Oral | Lab Hra Pharma | Labeling Revision |
| Megestrol Acetate | megestrol acetate | Suspension;Oral | Twi Pharms Inc | Approval |
| Metoprolol Tartrate | metoprolol tartrate | Injectable;Injection | Gland Pharma Ltd | Approval |
| Nephramine 5.4% | amino acids | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Olopatadine Hydrochloride | olopatadine hydrochloride | Solution;Ophthalmic | Watson Labs Inc | Tentative Approval |
| Phoslyra | calcium acetate | Solution;Oral | Fresenius Medcl | Manufacturing Change or Addition |
| Vimovo | esomeprazole magnesium; naproxen | Tablet, Delayed Release;Oral | Horizon Pharma | Manufacturing Change or Addition |
| Xopenex Hfa | levalbuterol tartrate | Aerosol, Metered;Inhalation | Sunovion | Manufacturing Change or Addition |
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