FDA — authorised 15 June 2007
- Application: NDA022081
- Marketing authorisation holder: GILEAD
- Local brand name: LETAIRIS
- Indication: TABLET — ORAL
- Status: approved
FDA authorised Ambrisentan Pill on 15 June 2007
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 June 2007; FDA has authorised it.
GILEAD holds the US marketing authorisation.