← FDA DRUG APPROVALS

FDA BLA · BLA761060

MYLOTARG

gemtuzumab ozogamicin

Sponsor: WYETH PHARMS INC

APPLICATION
BLA761060
TYPE
BLA
ORIGINAL APPROVAL
2017-09-01
LATEST ACTION
2020-06-16
ROUTE
INTRAVENOUS, SINGLE-DOSE
DOSAGE FORM
VIAL
MARKETING STATUS
Prescription

Products

MYLOTARGPrescription
GEMTUZUMAB OZOGAMICIN 4.5MG · VIAL · SINGLE-DOSE

Approval history

2020-06-16Efficacy · Supplement 4 · priority — Label ↗AP
2020-02-27Labeling · Supplement 3 · standard — Label ↗AP
2018-04-09Labeling · Supplement 1 · standard — Letter ↗AP
2017-09-01Type 4 - New Combination · Original · standard — Label ↗AP
2017-09-01Efficacy · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →