🇺🇸 Nexlizet in United States

Nexlizet (Nexlizet) regulatory status in United States.

Marketing authorisations

FDA

  • Status: approved

FDA

  • Application: ANDA219421
  • Marketing authorisation holder: ALKEM LABORATORIES LIMITED
  • Local brand name: BEMPEDOIC ACID AND EZETIMIBE
  • Indication: TABLET
  • Status: approved

Read official source →

Nexlizet in other countries

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

Other Other approved in United States

Frequently asked questions

Is Nexlizet approved in United States?

Yes. FDA has authorised it; FDA has authorised it.

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

University of Louisville is the originator. The local marketing authorisation holder may differ — check the official source linked above.