FDA
- Marketing authorisation holder: ROCHE
- Status: approved
🇺🇸 Hexapen in United States
Hexapen (Mecillinam) regulatory status in United States.
Marketing authorisation
Hexapen in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Hexapen approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for Hexapen in United States?
ROCHE holds the US marketing authorisation.