FDA — authorised 6 March 2012
- Marketing authorisation holder: DISCOVERY LABS
- Status: approved
🇺🇸 Surfaxin in United States
FDA authorised Surfaxin on 6 March 2012
Marketing authorisation
Surfaxin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Respiratory approved in United States
Frequently asked questions
Is Surfaxin approved in United States?
Yes. FDA authorised it on 6 March 2012.
Who is the marketing authorisation holder for Surfaxin in United States?
DISCOVERY LABS holds the US marketing authorisation.