CDER New June 29, 2017

What's New on the FDA Drugs Site

June 28, 2017

• Current Good Manufacturing Practice for Medical Gases Guidance for Industry (PDF - 219KB)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Approval Package:
  • Tigecycline Injection
  • Tirosint-SOL (levothyroxine sodium) Oral Solution
  • VIEKIRA XR (dasabuvir, ombitasvir, paritaprevir, and ritonavir) Extended Release Tablets
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Indigotindisulfonate Sodium (Indigo Carmine) Injection (Updated - Currently in Shortage)
  • Pantoprazole (Protonix) Powder for Injection (Updated - Currently in Shortage)
• Manual of Policies and Procedures (MAPP) 5015.8 Acceptance Criteria for Residual Solvents (PDF - 54KB)
• National Drug Code Directory
• Potassium Phosphate and Succinylcholine Chloride by PharMEDium Services: Recall - Lack of Sterility Assurance
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)