CDER New May 23, 2017

What's New on the FDA Drugs Site

May 22, 2017

• Drug Shortages
  • Galantamine Tablets (New - Discontinuation)
  • Glyburide Metformin Tablets (New - Discontinuation)
  • Glyburide Tablets (New - Discontinuation)
  • Indomethacin Capsules (New - Discontinuation)
  • Disopyramide Phosphate (Norpace) Capsules (Currently in Shortage)
• Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.)
• Drug Statement: FDA advises drug manufacturers that Burkholderia cepacia complex poses a contamination risk in non-sterile, water-based drug products
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA approves Actemra (tocilizumab), the first drug to specifically treat giant cell arteritis
• FDA Drug Safety Communication: FDA identifies no harmful effects to date with brain retention of gadolinium-based contrast agents for MRIs; review to continue 
• National Drug Code Directory
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)