FDA — authorised 2 July 2024
- Application: BLA761248
- Marketing authorisation holder: ELI LILLY CO
- Local brand name: KISUNLA
- Indication: INJECTABLE — INJECTION
- Status: approved
The FDA approved KISUNLA, a new molecular entity and new combination, for marketing by ELI LILLY CO on 2024-07-02. The approval was granted under the standard expedited pathway. The indications for KISUNLA are classified as Type 1 New Molecular Entity and Type 4 New Combination.