🇺🇸 Pombiliti in United States

FDA authorised Pombiliti on 28 September 2023

Marketing authorisation

FDA — authorised 28 September 2023

  • Application: BLA761204
  • Marketing authorisation holder: AMICUS THERAP US
  • Local brand name: POMBILITI
  • Indication: INJECTABLE — INJECTION
  • Status: approved

The FDA granted marketing authorisation to Pombiliti, a drug developed by AMICUS THERAP US, on 25 July 2024. The marketing authorisation was granted under the standard expedited pathway. The approved indication for Pombiliti is listed in its labelling, but the specific indication is not reported in the available data.

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Pombiliti in other countries

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

Other Metabolic approved in United States

Frequently asked questions

Is Pombiliti approved in United States?

Yes. FDA authorised it on 28 September 2023.

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

AMICUS THERAP US holds the US marketing authorisation.