CDER New May 2, 2016

What's New on the FDA Drugs Site

April 29, 2016

• FDA approves first generic Crestor
• FDA Drug Shortages
  • Atropine Sulfate Injection   (Updated - Currently in Shortage)
  • Bleomycin Sulfate for Injection   (Updated - Currently in Shortage)
  • Calcium Chloride Injection, USP   (Updated - Currently in Shortage)
  • Calcium Gluconate Injection   (Updated - Currently in Shortage)
  • Cefepime Injection   (Updated - Currently in Shortage)
  • Epinephrine Injection   (Updated - Currently in Shortage)
  • Imipenem and Cilastatin for Injection, USP   (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection   (Updated - Currently in Shortage)
  • Morphine Sulfate Injection, USP, CII, (Preservative-Free)(For PCA Use Only)   (Updated - Currently in Shortage)
  • Multi-Vitamin Infusion (Adult and Pediatric)   (Updated - Currently in Shortage)
  • Penicillin G Benzathine (Bicillin L-A) Injection (New - Currently in Shortage)
  • Piperacillin and Tazobactam (Zosyn) Injection   (Updated - Currently in Shortage)
  • Potassium Chloride Injection   (Updated - Currently in Shortage)
  • Sodium Bicarbonate Injection, USP   (Updated - Currently in Shortage)
  • Sodium Chloride 23.4% Injection   (Updated - Currently in Shortage)
  • Sumatriptan (Imitrex) Nasal Spray   (Updated - Currently in Shortage)
  • Vancomycin Hydrochloride for Injection, USP   (Updated - Currently in Shortage)
• Generic Drug Review Dashboard Report (update)
• GDUFA Reauthorization Negotiation Sessions (updated)
• Public Meeting on Patient-Focused Drug Development for Huntington’s and Parkinson’s Diseases(updated)
• Voice of the Patient: A Series of Reports from FDA's Patient-Focused Drug Development Initiative(updated)