CDER New June 24, 2013

What's New on the FDA Drugs Site
June 21, 2013

• FDA approves Vibativ for hospitalized patients with bacterial pneumonia
• Current Drug Shortages Index (updated)
  • New Drug Shortage: Sincalide (Kinevac) injection
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Guidance for Industry:  Bioequivalence Recommendations for Specific Products (updated) 
• FDA approves Plan B One-Step emergency contraceptive for use without a prescription for all women of child-bearing potential
• DOJ News Release: The Department of Justice Files Suit Against Louisiana Pharmaceutical Company for Distributing Unapproved and Misbranded Prescription and Over-the-counter Drugs
• FDA obtains waiver from European Commission to facilitate export for U.S. pharmaceutical manufacturers
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Reviews (FDASIA) (updated)
• National Drug Code Directory