← FDA DRUG APPROVALS

FDA BLA · BLA761040

BESPONSA

inotuzumab ozogamicin

Sponsor: WYETH PHARMS INC

APPLICATION
BLA761040
TYPE
BLA
ORIGINAL APPROVAL
2017-08-17
LATEST ACTION
2024-03-06
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER
MARKETING STATUS
Prescription

Products

BESPONSAPrescription
INOTUZUMAB OZOGAMICIN 0.9/MG/VIAL · POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER

Approval history

2024-03-06Efficacy · Supplement 3 · priority — Label ↗AP
2017-08-17Type 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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