New and Generic Drug Approvals
August 21, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Benazepril Hydrochloride and Hydrochlorothiazide | benazepril hydrochloride; | Tablet;Oral | Apotex Inc | Approval |
| Duodote | atropine; pralidoxime chloride | Injectable;Intramuscular | Meridian Medcl | Manufacturing Change or Addition |
| Elidel | pimecrolimus | Cream;Topical | Valeant Bermuda | Manufacturing Change or Addition |
| Eliquis | apixaban | Tablet;Oral | Bristol Myers Squibb | Efficacy Supplement with Clinical Data to Support |
| Kazano | alogliptin benzoate; metformin hydrochloride | Tablet;Oral | Takeda Pharms Usa | Manufacturing Change or Addition |
| Levocetirizine Dihydrochloride | levocetirizine dihydrochloride | Solution;Oral | Apotex Inc | Approval |
| Potassium Chloride | potassium chloride | Tablet, Extended Release;Oral | Mylan Pharms Inc | Approval |
| Pralidoxime Chloride | pralidoxime chloride | Injectable;Injection | Meridian Medcl Techn | Manufacturing Change or Addition |
| Prepopik | citric acid; magnesium oxide; sodium picosulfate | For Solution;Oral | Ferring Pharms As | Manufacturing Change or Addition |
| Retin-A Micro | tretinoin | Gel;Topical | Valeant Intl | Manufacturing Change or Addition |
| Retin-A-Micro | tretinoin | Gel;Topical | Valeant Intl | Manufacturing Change or Addition |
| Revatio | sildenafil citrate | Solution;Intravenous | Pfizer | Manufacturing Change or Addition |
| Rifampin | rifampin | Injectable;Injection | Fresenius Kabi Usa | Approval |
| Sandostatin Lar | octreotide acetate | Injectable;Injection | Novartis | Manufacturing Change or Addition |
| Zoledronic Acid | zoledronic acid | Injectable;Injection | Akorn Inc | Approval |
No comments:
Post a Comment