---------- Forwarded message ----------
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Thu, Jul 10, 2014 at 7:01 AM
Subject: CDER New July 10, 2014
To: iammejtm@gmail.com
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Thu, Jul 10, 2014 at 7:01 AM
Subject: CDER New July 10, 2014
To: iammejtm@gmail.com
What's New on the FDA Drugs Site
July 9, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drugs@FDA Data Files (updated)
- FDA Drug Shortages: New and Updated
- Bumetanide Injection (Currently in Shortage)
- Bupivacaine Hydrochloride (Marcaine, Sensorcaine) Injection (Currently in Shortage)
- Cefazolin Injection (Currently in Shortage)
- Chromic Chloride Injection (Currently in Shortage)
- Clindamycin Phosphate (Cleocin) Injection (Currently in Shortage)
- Copper Injection (Currently in Shortage)
- Dextrose 5% Injection Bags (Currently in Shortage)
- Ephedrine Sulfate Injection (Currently in Shortage)
- Fentanyl Citrate (Sublimaze) Injection (Currently in Shortage)
- Heparin Sodium Injection (Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Currently in Shortage)
- Lorazepam (Ativan) Injection (Resolved)
- Magnesium Sulfate Injection (Currently in Shortage)
- Morphine Sulfate (Astramorph PF, Duramorph, Infumorph) Injection (Preservative Free) (Currently in Shortage)
- Multi-Vitamin Infusion (Adult and Pediatric) (Currently in Shortage)
- Ondansetron (Zofran) Injection (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)
- Verapamil Hydrochloride Injection, USP (Currently in Shortage)
- Manual of Policies and Procedures (MAPP) 4657.9 Rev.4 Restoration of Forfeited Annual Leave (PDF - 128KB)
- National Drug Code Directory
New and Generic Drug Approvals
July 8, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Celexa | citalopram hydrobromide | Tablet;Oral | Forest Labs | Labeling Revision |
| Conray | iothalamate meglumine | Injectable;Injection | Mallinckrodt | Labeling Revision |
| Conray 43 | iothalamate meglumine | Injectable;Injection | Mallinckrodt | Labeling Revision |
| Crestor | rosuvastatin calcium | Tablet;Oral | Ipr | Labeling Revision |
| Frovatriptan Succinate | frovatriptan succinate | Tablet;Oral | Mylan Pharms Inc | Tentative Approval |
| Quetiapine Fumarate | quetiapine fumarate | Tablet, Extended Release;Oral | Mylan Pharms Inc | Tentative Approval |
| Valchlor | mechlorethamine hydrochloride | Gel;Topical | Actelion Pharms Ltd | Manufacturing Change or Addition |
| Vantas | histrelin acetate | Implant;Subcutaneous | Endo Pharm | Labeling Revision |
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Jeremy Tobias Matthews
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