What's New on the FDA Drugs Site
October 11, 2016
- CDER Statement: FDA analyses conclude that Xarelto clinical trial results were not affected by faulty monitoring device
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- FDA Drug Shortages
- Bleomycin Sulfate for Injection (Updated - Currently in Shortage)
- Cefepime Injection (Updated - Currently in Shortage)
- Dextrose Injection USP, 70% (Updated - Currently in Shortage)
- Famciclovir (Famvir) Tablets (New - Discontinuation)
- Imipenem and Cilastatin for Injection, USP (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- LifeCare PCA™ Sterile Empty Vial and Injector (Updated - Currently in Shortage)
- Morphine Sulfate Injection, USP, CII, (Preservative-Free)(For PCA Use Only) (Updated - Currently in Shortage)
- Multi-Vitamin Infusion (Adult and Pediatric) (Updated - Currently in Shortage)
- Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
- Potassium Chloride Injection (Updated - Currently in Shortage)
- Procainamide Hydrochloride Injection, USP (Updated - Currently in Shortage)
- Sodium Acetate Injection, USP (Updated - Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)
- Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)
- Sufentanil Citrate (Sufenta) Injection (Updated - Currently in Shortage)
- Tobramycin Injection (Updated - Currently in Shortage)
- Water-Miscible Vitamin A Palmitate (Aquasol A Parenteral) (Updated - Currently in Shortage)
- National Drug Code Directory
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
New and Generic Drug Approvals
October 7, 2016
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Carnexiv | carbamazepine | Injectable;Injection | Lundbeck Llc | Approval |
| Ceftriaxone and Dextrose In Duplex Container | ceftriaxone sodium | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Docetaxel | docetaxel | Injectable;Injection | Sandoz | Manufacturing Change or Addition |
| Epanova | omega-3-carboxylic acids | Capsule;Oral | Astrazeneca Pharms | Labeling Revision |
| Furosemide | furosemide | Tablet;Oral | Sandoz | Labeling Revision |
| Jentadueto | linagliptin; metformin hydrochloride | Tablet;Oral | Boehringer Ingelheim | Manufacturing Change or Addition |
| Nalfon | fenoprofen calcium | Capsule;Oral | Xspire | Manufacturing Change or Addition |
| Novolog | insulin aspart recombinant | Injectable;Subcutaneous | Novo Nordisk Inc | Labeling Revision |
| Novolog Flexpen | insulin aspart recombinant | Injectable;Subcutaneous | Novo Nordisk Inc | Labeling Revision |
| Novolog Flextouch | insulin aspart recombinant | Injectable;Subcutaneous | Novo Nordisk Inc | Labeling Revision |
| Novolog Innolet | insulin aspart recombinant | Injectable;Subcutaneous | Novo Nordisk Inc | Labeling Revision |
| Novolog Penfill | insulin aspart recombinant | Injectable;Subcutaneous | Novo Nordisk Inc | Labeling Revision |
| Oncaspar | pegaspargase | Vial | Sigma Tau | Labeling Revision |
| Quetiapine Fumarate | quetiapine fumarate | Tablet, Extended Release;Oral | Intellipharmaceutics | Tentative Approval |
| Skelaxin | metaxalone | Tablet;Oral | King Pharms | Manufacturing Change or Addition |
| Tracleer | bosentan | Tablet;Oral | Actelion Pharms Ltd | Manufacturing Change or Addition |
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Wednesday, October 12, 2016
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