FDA — authorised 15 December 2008
- Application: NDA022311
- Marketing authorisation holder: GENZYME
- Local brand name: MOZOBIL
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA authorised Weight-Based Plerixafor on 15 December 2008
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 15 December 2008; FDA has authorised it.
GENZYME holds the US marketing authorisation.