← FDA DRUG APPROVALS

FDA BLA · BLA761166

BESREMI

ropeginterferon alfa-2b

Sponsor: PHARMAESSENTIA CORP

APPLICATION
BLA761166
TYPE
BLA
ORIGINAL APPROVAL
2021-11-12
LATEST ACTION
2026-06-26
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

BESREMIPrescription
ROPEGINTERFERON ALFA-2B-NJFT 500 MCG/ML · INJECTABLE · SUBCUTANEOUS

Approval history

2026-06-26Labeling · Supplement 10 · standard — Letter ↗AP
2024-04-29Labeling · Supplement 7 · standard — Letter ↗AP
2021-11-12Type 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.

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