Orladeyo (berotralstat dihydrochloride)
New dosage formPriority review
- Region
- 🇺🇸 US
- Active substance
- berotralstat dihydrochloride
- Company
- Biocryst
- Status
- Approved
- FDA approval
- Thu 11 Dec 2025
- Designations
- New dosage form, Priority review
- Application
- NDA219776
- Official record
- www.accessdata.fda.gov
Regulatory milestones
Fri 12 Dec 2025🇺🇸 PDUFA datecompany-announced
ORLADEYO: PDUFA target action date (hereditary angioedema (HAE) in pediatric patients aged 2 to 11 years (oral granules))
Biocryst Pharmaceuticals Inc (BCRX); berotralstat; NDA; status: extended; "The new PDUFA target action date is December 12, 2025."; filed 2025-06-25 · source
Thu 11 Dec 2025🇺🇸 FDA approval
FDA approves Orladeyo (berotralstat dihydrochloride): new dosage form
Biocryst; NDA219776; New dosage form, Priority review; pellets · source
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.