NDA 214094, held by Biocryst. Berotralstat Dihydrochloride.
As of Nov 13, 2026, NDA 214094 (Orladeyo), held by Biocryst, was first approved by FDA on Dec 3, 2020, with 4 approved supplements and 0 published complete response letters.
ORLADEYO is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 2 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 3, 2020 | Original applicationNew molecular entity · Standard review | Approved |
| OrladeyoEQ 110MG BASE · capsule;oral | Berotralstat Dihydrochloride | RxReference drug |
| OrladeyoEQ 150MG BASE · capsule;oral | Berotralstat Dihydrochloride | RxReference drug |
| Oct 16, 2026 | Supplement 6Labeling · Standard review | Approved | |
| Dec 23, 2025 | Supplement 5Labeling · Standard review | Approved | |
| Oct 21, 2024 | Supplement 3Labeling · Standard review | Approved | |
| Nov 21, 2023 | Supplement 2Labeling · Standard review | Approved | |
| Dec 3, 2020 | Original applicationNew molecular entity · Standard review | Approved |
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
