FDA — authorised 20 September 1995
- Marketing authorisation holder: GLAXOSMITHKLINE LLC
- Status: approved
🇺🇸 Flolan in United States
FDA authorised Flolan on 20 September 1995
Marketing authorisations
FDA — authorised 20 September 1995
- Application: NDA020444
- Marketing authorisation holder: GLAXOSMITHKLINE LLC
- Local brand name: FLOLAN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 June 2008
- Application: NDA022260
- Marketing authorisation holder: ACTELION
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
FDA — authorised 12 June 2024
- Application: ANDA213913
- Marketing authorisation holder: MYLAN
- Status: approved
FDA — authorised 3 June 2025
- Application: ANDA210473
- Marketing authorisation holder: SUN PHARM
- Indication: Labeling
- Status: approved
The FDA approved Flolan, manufactured by SUN PHARM, for labeling on June 3, 2025. This approval was granted under the standard expedited pathway. The application number for this approval is ANDA210473.
FDA — authorised 29 December 2025
- Application: ANDA219237
- Marketing authorisation holder: GLAND
- Status: approved
Flolan in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Flolan approved in United States?
Yes. FDA authorised it on 20 September 1995; FDA authorised it on 20 September 1995; FDA authorised it on 27 June 2008.
Who is the marketing authorisation holder for Flolan in United States?
GLAXOSMITHKLINE LLC holds the US marketing authorisation.