June 12, 2026

• Orange Book
  • Approved Drug Products with Therapeutic Equivalence Evaluations
  • Orange Book Current Cumulative Supplement (updated)
  • Additions/Deletions for Prescription and OTC Drug Product Lists (updated)
  • Orange Book Data Files (compressed) (updated)
  • Reference Listed Drugs by ANDA Reference Standard List (updated)
  • Orange Book Patent Listing Dispute List (updated)
• Draft Guidance: Forms FDA 3542a and FDA 3542: Questions and Answers
• FDA approves belzutifan with pembrolizumab for adjuvant treatment of renal cell carcinoma
• FDA approves capivasertib with abiraterone and prednisone for PTEN-deficient androgen pathway modulation-naïve or -sensitive prostate cancer
• FDA Approves Drug for Pediatric Stage 3 Type I Diabetes

June 10, 2026

• Public Notifications:
  • Business Pill may be harmful due to hidden drug ingredient
  • Branch Manager for Men may be harmful due to hidden drug ingredient
• Webinar: ClinicalTrials.gov: Essentials for Academic Medical Centers
• Drug Safety Communication: FDA Approves Labeling Changes for Over-the-Counter (OTC) Weight Loss Drug alli (Orlistat) to Warn of Risk of Kidney Stones and Kidney Injury

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.