CDER New March 7, 2016

What's New on the FDA Drugs Site

March 4, 2016

• Electronic Submissions Presentations (updated)
• Environmental Assessment: Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity Guidance for Industry  ( PDF - 69KB)
• FDA Drug Shortages
  • Atropine Sulfate Injection   (Updated - Currently in Shortage)
  • Calcium Chloride Injection, USP   (Updated - Currently in Shortage)
  • Enoxaparin Sodium Injection (New - Discontinuation)
  • Epinephrine Injection   (Updated - Currently in Shortage)
  • Fentanyl Citrate (Sublimaze) 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)
  • 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 0.9% Injection Bags   (Updated - Currently in Shortage)
  • Sodium Chloride 23.4% Injection   (Currently in Shortage)
  • Tobramycin Injection   (Updated - Currently in Shortage)