CDER New June 23, 2016

What's New on the FDA Drugs Site

June 22, 2016

• Sabril (vigabatrin) Information
• Drug Approval Packages:
  • Axumin
  • NETSPOT
  • Tecentriq
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Doxorubicin Lyophilized Powder for Injection (Updated - Currently in Shortage)
  • Penicillin G Benzathine (Bicillin L-A) Injection (Updated - Currently in Shortage)
  • Theophylline Extended Release Tablets and Capsules (Updated - Currently in Shortage)
  • Tobramycin Injection (Updated - Currently in Shortage)
• FDA Regional Implementation Specifications for ICH E2B(R3) Implementation Postmarket Submission of Individual Case Safety Reports for Drugs and Biologics, Excluding Vaccines (PDF - 185KB)
• Paragraph IV Patent Certifications (updated)