🇺🇸 Fractionated 5-aminolevulinic acid hydrochloride 20% gel PDT in United States

Fractionated 5-aminolevulinic acid hydrochloride 20% gel PDT (Fractionated 5-aminolevulinic acid hydrochloride 20% gel PDT) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

Fractionated 5-aminolevulinic acid hydrochloride 20% gel PDT in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Fractionated 5-aminolevulinic acid hydrochloride 20% gel PDT approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Fractionated 5-aminolevulinic acid hydrochloride 20% gel PDT in United States?

Maastricht University Medical Center is the originator. The local marketing authorisation holder may differ — check the official source linked above.