FDA — authorised 20 December 2017
- Marketing authorisation holder: AETERNA ZENTARIS GMBH
- Status: approved
🇺🇸 Macrilen in United States
FDA authorised Macrilen on 20 December 2017
Marketing authorisations
FDA — authorised 20 December 2017
- Application: NDA205598
- Marketing authorisation holder: AETERNA ZENTARIS
- Local brand name: MACRILEN
- Indication: FOR SOLUTION — ORAL
- Status: approved
Macrilen in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Macrilen approved in United States?
Yes. FDA authorised it on 20 December 2017; FDA authorised it on 20 December 2017.
Who is the marketing authorisation holder for Macrilen in United States?
AETERNA ZENTARIS GMBH holds the US marketing authorisation.