What's New on the FDA Drugs Site
March 17, 2015
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug ShortagesNational Drug Code Directory
- Ammonium Chloride Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride (Marcaine, Sensorcaine) Injection (Updated - Currently in Shortage)
- Dextrose 5% Injection Bags (Updated - Currently in Shortage)
- Epinephrine Injection (Updated - Currently in Shortage)
- Haloperidol Lactate Injection (Updated - Currently in Shortage)
- Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
- Magnesium Sulfate Injection (Updated - Currently in Shortage)
- Morphine Sulfate (Astramorph PF, Duramorph, Infumorph) Injection (Preservative Free) (Updated - Currently in Shortage)
- Multi-Vitamin Infusion (Adult and Pediatric) (Updated - Currently in Shortage)
- Nalbuphine Hydrochloride (Nubain) Injection (Updated - Currently in Shortage)
- Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
- Potassium Chloride Injection (Updated - Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)
- Vancomycin Hydrochloride for Injection, USP (Updated - Currently in Shortage)
- Manual of Policies and Procedures (MAPP) 4180.4 NDAs/BLAs: Using the 21st Century Review Process Desk Reference Guide (PDF - 51KB) (Recertification)
- Pediatric Medical, Statistical, and Clinical Pharmacology BPCA Reviews (updated)
- Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (updated)
New and Generic Drug Approvals
March 16, 2015
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Actoplus Met Xr | metformin hydrochloride; pioglitazone hydrochloride | Tablet, Extended Release;Oral | Takeda Pharms Usa | Manufacturing Change or Addition |
| Augmentin Es-600 | amoxicillin; clavulanate potassium | For Suspension;Oral | Dr Reddys Labs Inc | Labeling Revision |
| Avandaryl | glimepiride; rosiglitazone maleate | Tablet;Oral | Sb Pharmco | Labeling Revision |
| Benzamycin Pak | benzoyl peroxide; erythromycin | Gel;Topical | Valeant Luxembourg | Manufacturing Change or Addition |
| Chlorhexidine Gluconate | chlorhexidine gluconate | Cloth;Topical | Sage Prods | Manufacturing Change or Addition |
| Contrave | bupropion hydrochloride; naltrexone hydrochloride | Tablet, Extended Release;Oral | Takeda Pharms Usa | Manufacturing Change or Addition |
| Depocyt | cytarabine | Injectable, Liposomal;Injection | Pacira Pharms Inc | Manufacturing Change or Addition |
| Duetact | glimepiride; pioglitazone hydrochloride | Tablet;Oral | Takeda Pharms Usa | Labeling Revision |
| Feraheme | ferumoxytol | Solution;Intravenous | Amag Pharms Inc | Labeling Revision |
| Invanz | ertapenem sodium | Injectable;Intramuscular, Iv (Infusion) | Merck Sharp Dohme | Manufacturing Change or Addition |
| Mephyton | phytonadione | Tablet;Oral | Valeant Pharms | Manufacturing Change or Addition |
| Norvir | ritonavir | Solution;Oral | Abbvie | Labeling Revision |
| Norvir | ritonavir | Tablet;Oral | Abbvie | Labeling Revision |
| Tamiflu | oseltamivir phosphate | For Suspension;Oral | Roche | Manufacturing Change or Addition |
| Viibryd | vilazodone hydrochloride | Tablet;Oral | Forest Labs Inc | Efficacy Supplement with Clinical Data to Support |
| Zecuity | sumatriptan succinate | System;Iontophoresis | Teva Branded Pharm | Manufacturing Change or Addition |
| Zinacef | cefuroxime sodium | Injectable;Injection | Covis Injectables | Manufacturing Change or Addition |
| Zinacef | cefuroxime sodium | Injectable;Intramuscular, Intravenous | Covis Injectables | Manufacturing Change or Addition |
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Wednesday, March 18, 2015
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