September 15, 2026
- Public Notifications:
- Drug Safety Communication: FDA Approves Additional Information in Labeling for Kybella (Deoxycholic Acid) Injection Warning of Adverse Reactions Associated with Unapproved Use
September 11, 2026
- FDA Approves First Therapy to Target Muscle Loss in Spinal Muscular Atrophy
- 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)
- FDA approves first treatment for children aged 4-11 years with APDS, a rare genetic disorder of the immune system
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.
