CDER New November 25, 2016

What's New on the FDA Drugs Site

 November 23, 2016

• Drug Review Package
  • Lansoprazole Delayed-Release Orally Disintegrating Tablets
• Drugs@FDA Data Files (updated)
•  FDA Drug Shortages
  • Elvitegravir (VITEKTA) Tablets (New - Discontinuation)
  • Telavancin (Vibativ) Injection (New - Discontinuation)
  • Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
• Submission of Quality Metrics Data Guidance for Industry (PDF - 340KB)
• Office of Translational Sciences (updated)
• Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (updated)
• Product-Specific Recommendations for Generic Drug Development: Cyclobenzaprine HCl (PDF - 26KB)
• Tri-Coast Pharmacy Inc. Voluntarily Recalling All Sterile Products Prepared Between May 17, 2016 and November 17, 2016 Due to Concern Over Lack of Sterility Assurance