🇺🇸 Levulan in United States

Levulan (AMINOLEVULINIC ACID) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

Levulan 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 Levulan approved in United States?

Yes. FDA has authorised it.

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

Sun Pharma is the originator. The local marketing authorisation holder may differ — check the official source linked above.