← FDA DRUG APPROVALS

FDA BLA · BLA761336

ANKTIVA

nogapendekin alfa inbakicept-pmln

Sponsor: ALTOR BIOSCIENCE, LLC, AN INDIRECT WHOLLY-OWNED SU

APPLICATION
BLA761336
TYPE
BLA
ORIGINAL APPROVAL
2024-04-22
LATEST ACTION
2024-04-22
ROUTE
INTRAVESICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

ANKTIVAPrescription
nogapendekin alfa inbakicept-pmln 400mcg/0.4 mL · SOLUTION · INTRAVESICAL

Approval history

2024-04-22Type 1 - New Molecular Entity · 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 →