NDA 214701, held by Blueprint Medicines. Pralsetinib.
As of Nov 13, 2026, NDA 214701 (Gavreto), held by Blueprint Medicines, was first approved by FDA on Dec 1, 2020, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 1, 2020 | Original applicationNew indication · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Gavreto100MG · capsule;oral | Pralsetinib | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
