What's New on the FDA Drugs Site
April 11, 2013
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- FDA Alerts Healthcare Providers that Drugs Distributed by Shamrock Medical Solutions May be Mislabeled
- National Drug Code Directory (updated)
- Summary: 2013 FDA Pharmacy Inspection Assignment
New and Generic Drug Approvals
April 10, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Ceftriaxone and Dextrose In Duplex Container | ceftriaxone sodium | Injectable; Injection | B Braun | Labeling Revision |
| Daysee | ethinyl estradiol; levonorgestrel | Tablet; Oral | Lupin Ltd | Approval |
| Janumet Xr | metformin hydrochloride; sitagliptin phosphate | Tablet, Extended Release; Oral | Merck Sharp Dohme | Manufacturing Change or Addition |
| Juxtapid | lomitapide mesylate | Capsule; Oral | Aegerion | Labeling Revision |
| Kalbitor | ecallantide | Injectable; Injection | Dyax Corp. | Labeling Revision |
| Levemir | insulin detemir recombinant | Injectable; Subcutaneous | Novo Nordisk Inc | Labeling Revision |
| Levemir Flexpen | insulin detemir recombinant | Injectable; Subcutaneous | Novo Nordisk Inc | Labeling Revision |
| Levemir Innolet | insulin detemir recombinant | Injectable; Subcutaneous | Novo Nordisk Inc | Labeling Revision |
| Levemir Penfill | insulin detemir recombinant | Injectable; Subcutaneous | Novo Nordisk Inc | Labeling Revision |
| Metformin Hydrochloride | metformin hydrochloride | Tablet, Extended Release; Oral | Sun Pharma Global | Tentative Approval |
| Prednisolone Sodium Phosphate | prednisolone sodium phosphate | Tablet, Orally Disintegrating; Oral | Mylan Pharms Inc | Approval |
| Pulmicort Respules | budesonide | Suspension; Inhalation | Astrazeneca | Manufacturing Change or Addition |
| Surfaxin | lucinactant | Suspension; Intratracheal | Discovery Labs | Manufacturing Change or Addition |
| Survanta | beractant | Suspension; Intratracheal | Abbvie | Manufacturing Change or Addition |
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