🇺🇸 SELARSDI in United States

FDA authorised SELARSDI on 16 April 2024

Marketing authorisation

FDA — authorised 16 April 2024

  • Application: BLA761343
  • Marketing authorisation holder: ALVOTECH USA INC
  • Local brand name: SELARSDI
  • Indication: INJECTABLE — INJECTION
  • Status: approved

The FDA granted marketing authorisation to ALVOTECH USA INC for SELARSDI on 18 October 2024. This approval was granted under the standard expedited pathway. The application number for this approval is BLA761343.

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SELARSDI 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 SELARSDI approved in United States?

Yes. FDA authorised it on 16 April 2024.

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

ALVOTECH USA INC holds the US marketing authorisation.