FDA — authorised 9 April 2009
- Application: NDA022129
- Marketing authorisation holder: SHIONOGI
- Local brand name: ULESFIA
- Indication: LOTION — TOPICAL
- Status: approved
FDA authorised Ulesfia on 9 April 2009
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 9 April 2009; FDA has authorised it.
SHIONOGI holds the US marketing authorisation.