🇺🇸 Replagal in United States

Replagal (AGALSIDASE ALFA) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

Replagal 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 Replagal approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Replagal in United States?

Marketing authorisation holder not available in our data.