CDER New November 18, 2011

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From: U.S. Food & Drug Administration (FDA)
Sent: 11/21/2011 5:38:45 PM
To: guyperea@live.com
Subject: CDER New November 18, 2011

What's New on the FDA Drugs Site

November 18, 2011

• Unapproved Ophthalmic Drug Products
  
  • Questions and Answers About FDA's Enforcement Action Against Unapproved Fluorescein Injection
  • Questions and Answers About FDA's Enforcement Action Against Unapproved Freshkote Sterile Ophthalmic Solution 
• Drug Safety Oversight Board Meeting, October 20, 2011, Public Summary
• National Drug Code Directory Data File Download (updated)

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New and Generic Drug Approvals

November 18, 2011

• Amoxil (amoxicillin) Chewable Tablets, Dr. Reddy’s Laboratories, Inc., Labeling Revision
• Amoxil (amoxicillin) Tablets, Dr. Reddy’s Laboratories, Inc., Labeling Revision
• Amoxil (amoxicillin) Oral Suspension, Dr. Reddy’s Laboratories, Inc., Labeling Revision
• Amoxil (amoxicillin) Chewable Tablets, Dr. Reddy’s Laboratories, Inc., Labeling Revision
• Ampyra (dalfampridine) Extended-Release Tablets, Acorda Therapeutics, Inc., Labeling Revision
• Cozaar (losartan potassium) Tablets, Merck Sharp & Dohme Corp., Labeling Revision
• Diflucan (fluconazole) Tablets, Pfizer, Inc., Labeling Revision
• Diflucan (fluconazole) IV, Pfizer, Inc., Labeling Revision
• Diflucan (fluconazole) Powder for Oral Suspension, Pfizer, Inc., Labeling Revision
• Eovist (gadoxetate disodium) I.V. Solution, Bayer Healthcare Pharmaceuticals, Labeling Revision
• Eprosartan Mesylate Tablets, Mylan Pharmaceuticals, Inc., Approval
• Erwinaze (asparaginase Erwinia chrysanthemi) Injection, EUSA Pharma, Inc., Approval
• Hyzaar (losartan potassium and hydrochlorothiazide) Tablets, Merck Sharp & Dohme Corp., Labeling Revision
• Kepivance (pa1ifermin) Injection, Biovitrum AB, Labeling Revision
• Lamivudine Tablets, Aurobindo Pharma, Ltd., Approval
• Prinivil (lisinopril) Tablets, Merck Sharp & Dohme Corp., Labeling Revision
• Prinzide (lisinopril and hydrochlorothiazide) Tablets, Merck Sharp & Dohme Corp., Labeling Revision
• Zithromax (azithromycin) Injection, Pfizer, Inc., Labeling Revision

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