New and Generic Drug Approvals
August 26, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Dostinex | cabergoline | Tablet;Oral | Pharmacia and Upjohn | Labeling Revision |
| Entecavir | entecavir | Tablet;Oral | Teva Pharms Usa | Approval |
| Furosemide | furosemide | Injectable;Injection | Emcure Pharms Ltd | Approval |
| Memantine Hydrochloride | memantine hydrochloride | Tablet;Oral | Macleods Pharms Ltd | Tentative Approval |
| Nevirapine | nevirapine | Tablet, Extended Release;Oral | Mylan Labs Ltd | Tentative Approval |
| Primaxin | cilastatin sodium; imipenem | Injectable;Injection | Merck | Manufacturing Change or Addition |
| Promacta | eltrombopag olamine | Tablet;Oral | Glaxosmithkline | Efficacy Supplement with Clinical Data to Support |
| Telmisartan | telmisartan | Tablet;Oral | Zydus Pharms Usa Inc | Approval |
| Telmisartan and Amlodipine | telmisartan;amlodipine | Tablet;Oral | Mylan Pharms Inc | Approval |
| Xalkori | crizotinib | Capsule;Oral | Pf Prism Cv | Manufacturing Change or Addition |
No comments:
Post a Comment