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FDA BLA · BLA761068

CRYSVITA

burosumab

Sponsor: KYOWA KIRIN

APPLICATION
BLA761068
TYPE
BLA
ORIGINAL APPROVAL
2018-04-17
LATEST ACTION
2026-04-23
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CRYSVITAPrescription
BUROSUMAB-TWZA 10MG/ML · INJECTABLE · INJECTION

Approval history

2026-04-23Efficacy · Supplement 11 · standard — Label ↗AP
2025-08-28Labeling · Supplement 9 · standard — Letter ↗AP
2020-06-18Efficacy · Supplement 5 · priority — Letter ↗AP
2019-09-27Efficacy · Supplement 3 · standard — Letter ↗AP
2019-09-27Efficacy · Supplement 4 · priority — Letter ↗AP
2018-04-17Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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