← FDA DRUG APPROVALS

FDA BLA · BLA761106

HERCEPTIN HYLECTA

trastuzumab and hyaluronidase-oysk

Sponsor: GENENTECH INC

APPLICATION
BLA761106
TYPE
BLA
ORIGINAL APPROVAL
2019-02-28
LATEST ACTION
2026-05-18
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

HERCEPTIN HYLECTAPrescription
TRASTUZUMAB AND HYALURONIDASE-OYSK 600MG · INJECTABLE · SUBCUTANEOUS

Approval history

2026-05-18Labeling · Supplement 14 · standard — Label ↗AP
2024-06-18Efficacy · Supplement 10 · standard — Letter ↗AP
2019-02-28Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗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.

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