CDER New June 20, 2017

What's New on the FDA Drugs Site

June 19, 2017

• ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions Guidance for Industry (PDF - 238KB)
• Clindamycin Injection ADD-Vantage Vials by Alvogen: Recall - Lack of Sterility Assurance
• FDA Drug Shortages
  • Disopyramide Phosphate (Norpace) Capsules (Updated - Currently in Shortage)