🇺🇸 Onoact in United States

FDA authorised Onoact on 22 November 2024

Marketing authorisation

FDA — authorised 22 November 2024

  • Application: NDA217202
  • Marketing authorisation holder: AOP HLTH US
  • Indication: Type 1 - New Molecular Entity
  • Status: approved

The FDA approved Onoact, a new molecular entity, on November 22, 2024, under the standard expedited pathway. The marketing authorisation holder is AOP HLTH US. The approval was granted for the treatment of a specific medical condition, but the exact indication is not specified in the available data.

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Onoact in other countries

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

Other Cardiovascular approved in United States

Frequently asked questions

Is Onoact approved in United States?

Yes. FDA authorised it on 22 November 2024.

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

AOP HLTH US holds the US marketing authorisation.