FDA — authorised 25 July 1974
- Application: BLA050114
- Marketing authorisation holder: ALLERQUEST
- Local brand name: PRE-PEN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA authorised Pre-Pen on 25 July 1974
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 25 July 1974.
ALLERQUEST holds the US marketing authorisation.