CDER New May 23, 2018

May 22, 2018

• FDA video series about biosimilar and interchangeable products  
• Report in Response to the Sunscreen Innovation Act
• Drugs@FDA Data Files (updated)
• Enforcement Policy -- OTC Sunscreen Drug Products Marketed Without an Approved Application Guidance for Industry (PDF - 163KB)
• FDA Drug Shortages
  • Aminocaproic Acid Injection, USP (Updated - Currently in Shortage)
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Bumetanide Injection, USP (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)
  • Dasabuvir Sodium; Ombitasvir; Paritaprevir; Ritonavir (Viekira XR) Tablets (New - Discontinuation)
  • Cefepime Injection (Updated - Currently in Shortage)
  • Deferoxamine Mesylate for Injection, USP (Updated - Currently in Shortage)
  • Dexrazoxane Injection (Updated - Currently in Shortage)
  • Dextrose 5% Injection Bags (Updated - Currently in Shortage)
  • Dextrose 50% Injection (Updated - Currently in Shortage)
  • Diazepam Injection, USP (Updated - Currently in Shortage)
  • Diltiazem Hydrochloride (Updated - Currently in Shortage)
  • Disopyramide Phosphate (Norpace) Capsules (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)
  • Guanfacine Hydrochloride Tablets (Updated - Currently in Shortage)
  • Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
  • Hydrochlorothiazide and Lisinopril Tablets (New - Discontinuation)
  • Hydromorphone Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Imipenem and Cilastatin for 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)
  • Lanoxin (digoxin) Tablets (New - Discontinuation)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage)
  • Magnesium Sulfate Injection (Updated - Currently in Shortage)
  • Methotrexate Sodium Injection (Updated - Currently in Shortage)
  • Methylphenidate Hydrochloride (QUILLICHEW ER) Extended-Release Chewable Tablets (Updated - Currently in Shortage)
  • Methylphenidate Hydrochloride (QUILLIVANT XR) for Extended-Release Oral Suspension (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)
  • Ombitasvir; Paritaprevir; Ritonavir (Technivie) Tablets (New - Discontinuation)
  • Ondansetron Hydrochloride Injection (Updated - Currently in Shortage)
  • Pantoprazole (Protonix) Powder for Injection (Updated - Currently in Shortage)
  • Penicillin G Benzathine and Penicillin G Procaine (Bicillin C-R) Injection (Updated - Currently in Shortage)
  • Penicillin G Procaine Injection (Updated - Currently in Shortage)
  • Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
  • Potassium Chloride Injection (Updated - Currently in Shortage)
  • Potassium Phosphate Injection (Updated - Currently in Shortage)
  • Procainamide Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Rocuronium Bromide Injection (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride injection (Updated - Currently in Shortage)
  • Sodium Acetate Injection, USP (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 (Updated - Currently in Shortage)
  • Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Spironolactone Tablets (New - Discontinuation)
  • Sterile Water (Updated - Currently in Shortage)
  • Thioridazine Hydrochloride Tablets (Updated - Currently in Shortage)
• Maximal Usage Trials for Topical Active Ingredients Being Considered for Inclusion in an Over-The-Counter Monograph: Study Elements and Considerations Guidance for Industry (PDF - 139KB)