FDA — authorised 21 September 2010
- Marketing authorisation holder: NOVARTIS
- Status: approved
🇺🇸 Gilenya in United States
FDA authorised Gilenya on 21 September 2010
Marketing authorisations
FDA — authorised 21 September 2010
- Application: NDA022527
- Marketing authorisation holder: NOVARTIS
- Local brand name: GILENYA
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA208559
- Marketing authorisation holder: MSN LABS PVT LTD
- Local brand name: FINGOLIMOD
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA207940
- Marketing authorisation holder: STANDARD CHEM AND PHARM CO LTD
- Local brand name: FINGOLIMOD
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA207965
- Marketing authorisation holder: PAR PHARM INC
- Local brand name: FINGOLIMOD
- Indication: CAPSULE — ORAL
- Status: approved
Gilenya in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Gilenya approved in United States?
Yes. FDA authorised it on 21 September 2010; FDA authorised it on 21 September 2010; FDA has authorised it.
Who is the marketing authorisation holder for Gilenya in United States?
NOVARTIS holds the US marketing authorisation.