NDA 220449, held by Boehringer Ingelheim. Nerandomilast.
As of Nov 13, 2026, NDA 220449 (Jascayd), held by Boehringer Ingelheim, was first approved by FDA on Dec 19, 2025, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 19, 2025 | Original applicationNew indication · Priority review | Approved |
| Jascayd9MG · tablet;oral | Nerandomilast | RxReference drug |
| Jascayd18MG · tablet;oral | Nerandomilast | 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
