🇺🇸 Taurolin in United States

FDA authorised Taurolin on 19 December 2024

Marketing authorisation

FDA — authorised 19 December 2024

  • Application: NDA214520
  • Marketing authorisation holder: CORMEDIX
  • Indication: Labeling
  • Status: approved

The FDA approved Taurolin, developed by CORMEDIX, for its approved indication. The approval was granted through a standard expedited pathway. Taurolin's marketing authorization was issued on December 19, 2024, with application number NDA214520.

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Taurolin in other countries

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

Other Immunology approved in United States

Frequently asked questions

Is Taurolin approved in United States?

Yes. FDA authorised it on 19 December 2024.

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

CORMEDIX holds the US marketing authorisation.