August 13, 2026

• Draft Guidance: Container Closure Systems for Human Drugs and Biological Products
•  Sepbember 16, 2026 Public Meeting on the Recommendations for Reauthorization of the Prescription Drug User Fee Act (PDUFA)

August 12, 2026

• Public Notifications:
  • B. MAGI may be harmful due to hidden ingredients
  • DMagic Plus may be harmful due to hidden ingredients
  • Premium OrgaZEN 10000 may be harmful due to hidden ingredient
  • Anaconda Premium 500K may be harmful due to hidden ingredient

This report displays final approvals and tentative approvals of original and supplemental applications for the two days beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this time span. For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA.