FDA — authorised 29 December 1986
- Application: NDA019353
- Marketing authorisation holder: RISING
- Local brand name: ALFENTA
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA authorised Alfenta on 29 December 1986
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 29 December 1986; FDA authorised it on 28 October 1999; FDA has authorised it.
RISING holds the US marketing authorisation.