What's New Related to Drugs

• Drug Approval Packages: 
  • Adzenys ER (amphetamine)nbsp;   
  • Altafluor Benox (fluorescein sodium and benoxinate hydrochloride ophthalmic solution)
  • CaroSpir (Spironolactone)
  • Drax Exametazime (Kit for the Preparation of Tc99m Exametazime for leukocyte)
  • Duzallo (lesinurad/allopurinol)
  • Endari (L-glutamine)
  • Lumify (brimonidine tartrate)
  • Yosprala (aspirin 81 mg/omeprazole 40 mg, and aspirin 325 mg/omeprazole 40 mg)
  • ZILRETTA (triamcinolone acetonide)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated) 
• Drugs@FDA Data Files (updated)
• E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population Guidance for Industry (PDF - 355KB)
• FDA Drug Shortages
  • Amoxapine Tablets (Updated - Currently in Shortage)
  • Atenolol Tablets (Updated - Currently in Shortage)
  • Cromolyn Sodium Inhalation Solution, USP (Updated - Currently in Shortage)
  • Dorzolamide Hydrochloride and Timolol Maleate (Cosopt) Ophthalmic Solution (Updated - Currently in Shortage)
  • Etoposide Injection (Updated - Currently in Shortage)
  • Guanfacine Hydrochloride Tablets (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
  • Progesterone Injection, USP (Updated - Currently in Shortage)
• First Generic Drug Approvals (updated)
• National Drug Code Directory (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)