What's New on the FDA Drugs Site
August 13, 2012
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- DIA/FDA Industry PDUFA V Conference, October 18-19, 2012, Hilton Crystal City at Washington Reagan National Airport 2399 Jefferson Davis Hwy. Arlington, VA. Meeting information and registration
- National Drug Code Directory (updated)
New and Generic Drug Approvals
August 10, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Alfuzosin Hydrochloride | alfuzosin hydrochloride | Tablet, Extended Release; Oral | Wockhardt | Approval |
| Complera | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | Tablet; Oral | Gilead Sciences Inc | Labeling Revision |
| Edurant | rilpivirine hydrochloride | Tablet; Oral | Janssen Prods | Labeling Revision |
| Epinephrine | epinephrine | Injectable; Injection | Intelliject Inc. | Approval |
| Fuzeon | enfuvirtide | Injectable; Subcutaneous | Roche | Labeling Revision |
| Intelence | etravirine | Tablet; Oral | Janssen R and D | Labeling Revision |
| Irbesartan | irbesartan | Tablet; Oral | Prinston Pharma Inc | Tentative Approval |
| Isentress | raltegravir potassium | Tablet; Oral | Merck Sharp Dohme | Labeling Revision |
| Isentress | raltegravir potassium | Tablet, Chewable; Oral | Merck Sharp Dohme | Labeling Revision |
| Lucentis | ranibizumab | Injectable; Injection | Genentech | Efficacy Supplement with Clinical Data to Support |
| Lucentis | ranibizumab | Injectable; Injection | Genentech | Labeling Revision |
| Oxaliplatin | oxaliplatin | Injectable; Iv (Infusion) | Teva Pharms | Labeling Revision |
| Rescriptor | delavirdine mesylate | Tablet; Oral | Viiv Hlthcare | Labeling Revision |
| Selzentry | maraviroc | Tablet; Oral | Viiv Hlthcare | Labeling Revision |
| Suboxone | buprenorphine hydrochloride; naloxone hydrochloride | Film; Sublingual | Reckitt Benckiser | Manufacturing Change or Addition |
| Sustiva | efavirenz | Capsule; Oral | Bristol Myers Squibb | Labeling Revision |
| Sustiva | efavirenz | Tablet; Oral | Bristol Myers Squibb | Labeling Revision |
| Tranexamic Acid | tranexamic acid | Tablet; Oral | Apotex Inc | Tentative Approval |
| Vancomycin Hydrochloride | vancomycin hydrochloride | Injectable; Injection | Sagent Pharms | Approval |
| Vancomycin Hydrochloride | sterile vancomycin hydrochloride | Injectable; Injection | Sandoz Inc | Approval |
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