NDA 218808, held by Neurocrine. Crinecerfont.
As of Nov 13, 2026, NDA 218808 (Crenessity), held by Neurocrine, was first approved by FDA on Dec 13, 2024, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 13, 2024 | Original applicationNew molecular entity · Priority review | Approved |
| Crenessity25MG · capsule;oral | Crinecerfont | RxReference drug |
| Crenessity50MG · capsule;oral | Crinecerfont | RxReference drug |
| Crenessity100MG · capsule;oral | Crinecerfont | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
