CDER New April 28, 2017

What's New on the FDA Drugs Site

April 27, 2017

• FDA approves Brineura (cerliponase alfa), the first treatment for a form of Batten disease
• FDA expands the approved use of Stivarga (regorafinib) to treat liver cancer
• FDA Drug Safety Communication: FDA approves label changes for use of general anesthetic and sedation drugs in young children
• FDA Drug Safety Podcast: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women
• FDA Drug Shortages
  • Canakinumab (Ilaris) Lyophilized Powder for Injection (New - Discontinuation)
  • Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
  • Procainamide Hydrochloride Injection, USP (New - Currently in Shortage)   
  •  Rocuronium Bromide Injection (Updated - Currently in Shortage)
  • Scopolamine (Transderm Scop) Transdermal System Patch (Updated - Currently in Shortage)
• Medication Guides Page (Updated)