🇺🇸 SIMLANDI in United States

FDA authorised SIMLANDI on 23 February 2024

Marketing authorisation

FDA — authorised 23 February 2024

  • Application: BLA761299
  • Marketing authorisation holder: ALVOTECH USA INC
  • Local brand name: SIMLANDI
  • Indication: INJECTABLE — INJECTION
  • Status: approved

The FDA approved SIMLANDI, a drug developed by ALVOTECH USA INC, on 26 August 2024. The approval was granted under the standard expedited pathway. The marketing authorisation holder is ALVOTECH USA INC, and the application number is BLA761299.

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SIMLANDI 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 SIMLANDI approved in United States?

Yes. FDA authorised it on 23 February 2024.

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

ALVOTECH USA INC holds the US marketing authorisation.