CDER New August 23, 2018

August 22, 2018

• Drug Approval Packages:
  • Mektovi
  • Mulpleta (lusutrombopag)
  • Orilissa (elagolix sodium)
• Drug Trials Snapshots: POTELIGEO
• FDA Drug Shortages
  • Darifenacin Hydrobromide Tablets (New - Discontinuation)
  • Prednisolone Acetate 1% Ophthalmic Suspension (New - Discontinuation)
• Osteoarthritis: Structural Endpoints for the Development of Drugs (PDF - 60KB)