FDA — authorised 23 October 2015
- Application: BLA125513
- Marketing authorisation holder: ALEXION PHARM
- Local brand name: STRENSIQ
- Indication: SOLUTION — INJECTION
- Status: approved
FDA authorised Strensiq on 23 October 2015
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 23 October 2015.
ALEXION PHARM holds the US marketing authorisation.