🇺🇸 İsotretinoin in United States

İsotretinoin (İsotretinoin) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

İsotretinoin 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 İsotretinoin approved in United States?

Yes. FDA has authorised it.

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

SB Istanbul Education and Research Hospital is the originator. The local marketing authorisation holder may differ — check the official source linked above.