What's New on the FDA Drugs Site
December 4, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA approves Jakafi (ruxolitinib) to treat patients with a chronic type of bone marrow disease
- FDA Drug Info Rounds: USP Salt Policy (December 2014)
- FDA Drug Shortages: New and Updated
- Bupivacaine Hydrochloride (Marcaine, Sensorcaine) Injection (Currently in Shortage)
- Clindamycin Phosphate (Cleocin) Injection (Currently in Shortage)
- Dextrose 5% Injection Bags (Currently in Shortage)
- Dextrose Injection USP, 70% (Currently in Shortage)
- Fentanyl Citrate (Sublimaze) Injection (Currently in Shortage)
- Heparin Sodium Injection (Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Currently in Shortage)
- Magnesium Sulfate Injection (Currently in Shortage)
- Morphine Sulfate (Astramorph PF, Duramorph, Infumorph) Injection (Preservative Free) (Currently in Shortage)
- Piperacillin and Tazobactam (Zosyn) Injection (Currently in Shortage)
- Potassium Chloride Injection (Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (Currently in Shortage)
- Sterile Water for Injection Solutions (Currently in Shortage)
- Vancomycin Hydrochloride for Injection, USP (Currently in Shortage)
- Verapamil Hydrochloride Injection, USP (Currently in Shortage)
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- Guidance for Industry: How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD (PDF - 72KB)
- National Drug Code Directory
- Pregnancy and Lactation Labeling Final Rule (updated)
New and Generic Drug Approvals
December 3, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Blincyto | blinatumomab | Injectable;Injection | Amgen | Approval |
| Iquix | levofloxacin | Solution/Drops;Ophthalmic | Santen | Labeling Revision |
| Premarin | estrogens, conjugated | Tablet;Oral | Wyeth Pharms Inc | Labeling Revision |
| Quixin | levofloxacin | Solution/Drops;Ophthalmic | Santen | Labeling Revision |
| Survanta | beractant | Suspension;Intratracheal | Abbvie | Manufacturing Change or Addition |
| Tecfidera | dimethyl fumarate | Capsule, Delayed Release;Oral | Biogen Idec Inc | Efficacy Supplement with Clinical Data to Support |
| Tecfidera | dimethyl fumarate | Capsule, Delayed Release;Oral | Biogen Idec Inc | Labeling Revision |
| Vibativ | telavancin hydrochloride | Powder;Iv (Infusion) | Theravance Biopharma | Labeling Revision |
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