BESREMi (ropeginterferon alfa-2b-njft)

FDA PDUFA Target Action Date · PharmaEssentia Corporation

Sunday, August 30, 2026

53 days away

Drug Information

Drug Name: BESREMi (ropeginterferon alfa-2b-njft) (CT.gov)
Application Type: sBLA
Indication: Essential thrombocythemia (label expansion; approved in polycythemia vera)

Filing Details

Company: PharmaEssentia Corporation →
SEC CIK
Source: Company PR →

What is a PDUFA Date?

A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.

Standard Review: 10 months from filing acceptance
Priority Review: 6 months from filing acceptance
Possible Outcomes: Approval, Complete Response Letter (CRL), or extension

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Data sourced from SEC EDGAR filings. Last updated: 2026-06-29. Report an issue