What's New on the FDA Drugs Site

June 9, 2011

Drug Safety Oversight Board Meeting, May 19, 2011, Public Summary
FDA Drug Safety Communication: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer
Questions and Answers: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer
FDA Drug Safety Podcast for Healthcare Professionals: New restrictions, contraindications, and dose limitations for Zocor (simvastatin) to reduce the risk of muscle injury
Medication Guides (updated)
New and Generic Drug Approvals

June 9, 2011

Heparin Sodium Injection, Sandoz Inc., Approval
Heparin Sodium Injection, Sandoz Inc., Approval
Heparin Sodium Injection, Sandoz Inc., Approval
Lopinavir and Ritonavir Tablets, Mylan Pharmaceuticals, Inc., Tentative Approval
Mycamine (micafungin sodium) Injection, Astellas Pharma US, Inc., Labeling Revision
Zmax (azithromycin) Extended-Release Oral Suspension, Pfizer Global Research and Development, Labeling Revision