---------- Forwarded message ----------
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Fri, Jul 18, 2014 at 7:10 AM
Subject: CDER New July 18, 2014
To: iammejtm@gmail.com
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Fri, Jul 18, 2014 at 7:10 AM
Subject: CDER New July 18, 2014
To: iammejtm@gmail.com
What's New on the FDA Drugs Site
July 17, 2014
- FDA Drug Shortages: New and Updated
- Bupivacaine Hydrochloride (Marcaine, Sensorcaine) Injection (Currently in Shortage)
- Calcium Gluconate Injection (Currently in Shortage)
- Cefazolin Injection (Currently in Shortage)
- Clindamycin Phosphate (Cleocin) Injection (Currently in Shortage)
- Heparin Sodium Injection (Currently in Shortage)
- Leucovorin Calcium Lyophilized Powder for Injection (Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Currently in Shortage)
- Magnesium Sulfate Injection (Currently in Shortage)
- Ondansetron (Zofran) Injection (Currently in Shortage)
- Phosphate (Glycophos) Injection (Currently in Shortage)
- Sodium Chloride 23.4% Injection (Currently in Shortage)
- Tobramycin Solution for Injection (Currently in Shortage)
- Baxter Initiates Voluntary Worldwide Recall Of Four Lots Of IV Solutions Due To The Presence Of Particulate Matter
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Manual of Policies and Procedures (MAPP) 4643.5 Conference Room Management (PDF - 143KB)
- National Drug Code Directory
- Pediatric Medical, Statistical, and Clinical Pharmacology BPCA and PREA Reviews (updated)
New and Generic Drug Approvals
July 16, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Hexadrol | dexamethasone sodium phosphate | Injectable;Injection | Organon Usa Inc | Labeling Revision |
| Khedezla | desvenlafaxine | Tablet, Extended Release;Oral | Osmotica Pharm Corp | Labeling Revision |
| Promacta | eltrombopag olamine | Tablet;Oral | Glaxosmithkline | Labeling Revision |
| Viibryd | vilazodone hydrochloride | Tablet;Oral | Forest Labs Inc | Labeling Revision |
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Jeremy Tobias Matthews
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