-----Original Message-----
From: U.S. Food & Drug Administration (FDA)
Sent: 11/18/2011 3:56:55 PM
To: guyperea@live.com
Subject: CDER New November 17, 2011
What's New on the FDA Drugs Site
November 17, 2011
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (ZIP - 378KB)
- Drug Shortages: Current Drug Shortages: Vecuronium Injection (updated)
- Drug Shortages: Resolved Drug Shortages: Oxsoralen-Ultra (methoxsalen) 10 mg capsules
- Drug Shortages: Resolved Drug Shortages: Streptomycin for Injection, USP
- Guidance for Industry: Medication Guides â€" Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)(PDF - 92KB)
- Medication Guides (updated)
- Role of Naloxone in Opioid Overdose Fatality Prevention; Request for Comments; Public Workshop, April 12, 2012, FDA White Oak Campus Building 31, 10903 New Hampshire Avenue, Silver Spring, MD. Meeting information
November 16, 2011
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (ZIP - 378KB)
- Drug Shortages: Current Drug Shortages: Bleomycin Injection (updated)
- Drug Shortages: Current Drug Shortages: Bupivacaine Hydrochloride Injection (updated)
- Drug Shortages: Current Drug Shortages: Calcitriol 1 mcg/mL Injection (updated)
- Drug Shortages: Current Drug Shortages: Diltiazem Injection (updated)
- Drug Shortages: Current Drug Shortages: Lorazepam Injection (updated)
- Drug Shortages: Current Drug Shortages: Magnesium Sulfate Injection (updated)
- Drug Shortages: Current Drug Shortages: Phytonadione Injectable Emulsion (Vitamin K) (updated)
- Drug Shortages: Current Drug Shortages: Potassium Phosphate (updated)
- Drug Shortages: Current Drug Shortages: Vincristine Sulfate Injection (updated)
- Drugs@FDA Download File (updated)
- FDA approves Jakafi (ruxolitinib), the first drug to treat patients with the rare bone marrow disease myelofibrosis
- Orange Book (updated)
New and Generic Drug Approvals
November 17, 2011
- Imipenem and Cilastatin Injection, Hospira, Inc., Approval
- VFEND (voriconazole) Tablets, Pfizer, Inc., Labeling Revision
- VFEND I.V. (voriconazole) Infusion, Pfizer, Inc., Labeling Revision
- VFEND (voriconazole) Oral Suspension, Pfizer, Inc., Labeling Revision
November 16, 2011
- Acetaminophen and Codeine Phosphate Oral Solution, Vintage Pharmaceuticals, Approval
- Avandia (rosiglitazone maleate) Tablets, SB Pharmco, Labeling Revision
- Avandaryl (rosiglitazone maleate and glimepiride) Tablets, SB Pharmco, Labeling Revision
- Avandamet (rosiglitazone maleate and metformin hydrochloride) Tablets, SB Pharmco, Labeling Revision
- Carboplatin I.V. Injection, Onco Therapies Ltd., Approval
- Cerebyx (fosphenytoin sodium) Injection, Pfizer Inc., Labeling Revision
- Cipro (ciprofloxacin hydrochloride) Tablets, Bayer HealthCare Pharmaceuticals Inc., Labeling Revision
- Cipro (ciprofloxacin) Oral Suspension, Bayer HealthCare Pharmaceuticals Inc., Labeling Revision
- Cipro (ciprofloxacin) Injection, Bayer HealthCare Pharmaceuticals Inc., Labeling Revision
- Cipro in Dextrose 5% in plastic container (ciprofloxacin) Injection, Bayer HealthCare Pharmaceuticals Inc., Labeling Revision
- Cipro XR (ciprofloxacin) Extended-Release Tablets, Bayer HealthCare Pharmaceuticals Inc., Labeling Revision
- Dilantin (phenytoin sodium) Injection, Pfizer Inc., Labeling Revision
- Forfivo XL (bupropion hydrochloride) Extended-Release Tablets, IntelGenx Corp., Labeling Revision
- Jakafi (ruxolitinib) Tablets, Incyte Corp., Approval
- Kombiglyze XR (saxagliptin and metformin hydrochloride) Extended-Release Tablets, Bristol-Myers Squibb Co., Labeling Revision
- Lioresal (baclofen) Intrathecal Injection, Medtronic Neuromodulation, Labeling Revision
- Morphine Sulfate Extended-Release Capsules, Watson Laboratories, Inc., Labeling Revision
- Onglyza (saxagliptin hydrochloride) Tablets, Bristol-Myers Squibb Company, Labeling Revision
- Trobicin (spectinomycin hydrochloride) Injection, Pfizer, Inc., Labeling Revision
- Vanos (fluocinonide) Cream, Medicis Pharmaceutical Corp., Labeling Revision
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