← FDA DRUG APPROVALS

FDA BLA · BLA761424

JUBEREQ

denosumab-desu

Sponsor: ACCORD BIOPHARMA INC.

APPLICATION
BLA761424
TYPE
BLA
ORIGINAL APPROVAL
2025-10-29
LATEST ACTION
2025-10-29
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

OSVYRTIPrescription
denosumab-desu 60MG/ML · INJECTABLE · SUBCUTANEOUS
JUBEREQPrescription
denosumab-desu 120MG/1.7ML · INJECTABLE · SUBCUTANEOUS

Approval history

2025-10-29UNKNOWN · Original · standardLetterAP
VIEW ON DRUGS@FDA ↗

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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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