FDA — authorised 28 July 1997
- Application: NDA020381
- Marketing authorisation holder: ABBVIE
- Local brand name: NIASPAN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA authorised combined treatment on 28 July 1997
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 28 July 1997; FDA has authorised it.
ABBVIE holds the US marketing authorisation.