CDER New August 9, 2018

August 8, 2018

• Comunicaciones de la FDA sobre la seguridad de los medicamentos: La FDA advierte acerca del incremento del riesgo de reincidencia del cáncer con el uso del antibiótico azitromicina (Zithromax, Zmax) a largo plazo posterior a un trasplante de células madre de donante
• Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances Guidance for Industry (PDF - 103KB)
• FDA approves Poteligeo (mogamulizumab-kpkc) for the treatment of two rare types of non-Hodgkin lymphoma
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Shortages
  • Aminocaproic Acid Injection, USP (Updated - Currently in Shortage)
  • Aminophylline 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 5% Injection Bags (Updated - Currently in Shortage)
  • Diazepam Injection, USP (Updated - Currently in Shortage)
  • Diltiazem Hydrochloride (Updated - Currently in Shortage)
  • Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
  • Dopamine Hydrochloride Injection (Updated - Currently in Shortage)
  • Epinephrine Injection, 0.1 mg/mL (Updated - Currently in Shortage)
  • Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection, USP (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)
  • Metoclopramide Injection, USP (Updated - Currently in Shortage)
  • Metronidazole Injection, USP (Updated - Currently in Shortage)
  • Morphine Sulfate Injection, USP (Updated - Currently in Shortage)
  • Multi-Vitamin Infusion (Adult and Pediatric) (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)
  • Procainamide Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Promethazine (Phenergan) Injection (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Sodium Acetate Injection, USP (Updated - Currently in Shortage)
  • Sodium Chloride 0.9% Injection Bags (Currently in Shortage)
  • Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)
  • Sodium Chloride Injection USP, 0.9% Vials and Syringes (Updated - Currently in Shortage)
  • Sterile Water (Updated - Currently in Shortage)
• National Drug Code Directory (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)