What's New on the FDA Drugs Site
August 31, 2012
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- FDA approves Xtandi (enzalutamide), a new treatment for a type of late stage prostate cancer
New and Generic Drug Approvals
August 30, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Alfuzosin Hydrochloride | alfuzosin hydrochloride | Tablet, Extended Release; Oral | Aurobindo Pharma | Approval |
| Bupropion Hydrochloride | bupropion hydrochloride | Tablet, Extended Release; Oral | Wockhardt Ltd | Approval |
| Linzess | linaclotide | Capsule; Oral | Forest Labs Inc | Approval |
| Neoral | cyclosporine | Capsule; Oral | Novartis | Labeling Revision |
| Neoral | cyclosporine | Solution; Oral | Novartis | Labeling Revision |
| Revatio | sildenafil citrate | Tablet; Oral | Pfizer | Efficacy Supplement with Clinical Data to Support |
| Revatio | sildenafil citrate | Solution; Intravenous | Pfizer | Efficacy Supplement with Clinical Data to Support |
| Revatio | sildenafil | Suspension; Oral | Pfizer Inc | Approval |
| Sandimmune | cyclosporine | Injectable; Injection | Novartis | Labeling Revision |
| Sandimmune | cyclosporine | Solution; Oral | Novartis | Labeling Revision |
| Sandimmune | cyclosporine | Capsule; Oral | Novartis | Labeling Revision |
| Subsys | fentanyl | Spray; Sublingual | Insys Therap | Labeling Revision |
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