🇺🇸 Ngenla in United States

FDA authorised Ngenla on 27 June 2023

Marketing authorisation

FDA — authorised 27 June 2023

  • Application: BLA761184
  • Marketing authorisation holder: PFIZER IRELAND PHARMACEUTICALS
  • Local brand name: NGENLA
  • Indication: INJECTABLE — INJECTION
  • Status: approved

The FDA approved Ngenla, a drug developed by Pfizer Ireland Pharmaceuticals, on 9 July 2025. The approval was granted through the standard expedited pathway. The marketing authorisation holder is Pfizer Ireland Pharmaceuticals, and the application number is BLA761184.

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Ngenla 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 Ngenla approved in United States?

Yes. FDA authorised it on 27 June 2023.

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

PFIZER IRELAND PHARMACEUTICALS holds the US marketing authorisation.