🇺🇸 Mitchga in United States

FDA authorised Mitchga on 26 June 2025

Marketing authorisation

FDA — authorised 26 June 2025

Application: BLA761390
Marketing authorisation holder: GALDERMA LABS LP
Indication: Labeling
Status: approved

The FDA approved Mitchga, a product of GALDERMA LABS LP, for its approved indication on June 26, 2025. The application number for this approval is BLA761390. Mitchga was granted standard expedited pathway approval.

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Mitchga 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 Mitchga approved in United States?

Yes. FDA authorised it on 26 June 2025.

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

GALDERMA LABS LP holds the US marketing authorisation.