CDER New July 23, 2018

July 20, 2018

• FDA approves Tibsovo (ivosidenib), the first targeted treatment for patients with relapsed or refractory acute myeloid leukemia who have a certain genetic mutation
• FDA Drug Shortages
  • Aminocaproic Acid Injection, USP (Updated - Currently in Shortage)
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride and Epinephrine Injection, USP (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Calcium Chloride Injection, USP (Updated - Currently in Shortage)
  • Dextrose 50% Injection (Updated - Currently in Shortage)
  • Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
  • Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
  • Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Ketamine Injection (Updated - Currently in Shortage)
  • Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
  • Labetalol Hydrochloride Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage)
  • Lorazepam Injection, USP (Updated - Currently in Shortage)
  • Magnesium Sulfate Injection (Updated - Currently in Shortage)
  • Morphine Sulfate Injection, USP (Updated - Currently in Shortage)
  • Ondansetron Hydrochloride Injection (Updated - Currently in Shortage)
  • Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
  • Potassium Chloride Injection (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Sodium Acetate Injection, USP (Updated - Currently in Shortage)
  • Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)
  • Sodium Chloride Injection USP, 0.9% Vials (Updated - Currently in Shortage)
  • Sterile Water (Updated - Currently in Shortage)
• Product-Specific Guidances for Generic Drug Development (updated)