← FDA DRUG APPROVALS

FDA BLA · BLA761406

YESINTEK

ustekinumab

Sponsor: BIOCON BIOLOGICS INC

APPLICATION
BLA761406
TYPE
BLA
ORIGINAL APPROVAL
2024-11-29
LATEST ACTION
2026-01-07
ROUTE
SUBCUTANEOUS, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

YESINTEKPrescription
USTEKINUMAB-KFCE 45MG/0.5ML · INJECTABLE · INJECTION
YESINTEKPrescription
USTEKINUMAB-KFCE 90MG/ML · INJECTABLE · INJECTION

Approval history

2026-01-07BIOSIMILAR · Supplement 1 — Label ↗AP
2025-04-30UNKNOWN · Original · standard — Letter ↗AP
2024-11-29Type 2 - New Active Ingredient · 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.

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 →