🇺🇸 Ecclock in United States

FDA authorised Ecclock on 18 June 2024

Marketing authorisation

FDA — authorised 18 June 2024

  • Application: NDA217347
  • Marketing authorisation holder: BOTANIX SB
  • Local brand name: SOFDRA
  • Indication: GEL, METERED — TOPICAL
  • Status: approved

The FDA approved Ecclock, a new molecular entity, on 18 June 2024. The marketing authorisation was granted to BOTANIX SB under standard expedited pathway. The approval was based on the NDA217347 application.

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Ecclock 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 Ecclock approved in United States?

Yes. FDA authorised it on 18 June 2024.

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

BOTANIX SB holds the US marketing authorisation.