FDA — authorised 19 January 2001
- Application: BLA103949
- Marketing authorisation holder: SCHERING
- Local brand name: PEGINTRON
- Indication: VIAL
- Status: approved
FDA authorised PEG-IFN alfa-2b on 19 January 2001
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 19 January 2001; FDA has authorised it.
SCHERING holds the US marketing authorisation.