🇺🇸 Entereg in United States

FDA authorised Entereg on 19 December 2019

Marketing authorisations

FDA — authorised 19 December 2019

  • Application: ANDA208295
  • Marketing authorisation holder: WATSON LABS TEVA
  • Local brand name: ALVIMOPAN
  • Indication: CAPSULE — ORAL
  • Status: approved

The FDA approved Entereg for a Risk Evaluation and Mitigation Strategy (REMS) indication on 23 September 2025. This approval was granted to Watson Labs Teva, the marketing authorisation holder. Entereg's approval was processed through the standard expedited pathway.

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FDA — authorised 24 January 2023

  • Application: ANDA216843
  • Marketing authorisation holder: PH HEALTH
  • Local brand name: ALVIMOPAN
  • Indication: CAPSULE — ORAL
  • Status: approved

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FDA — authorised 31 August 2023

  • Application: ANDA217753
  • Marketing authorisation holder: HIKMA
  • Local brand name: ALVIMOPAN
  • Indication: CAPSULE — ORAL
  • Status: approved

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Entereg in other countries

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

Other Pain approved in United States

Frequently asked questions

Is Entereg approved in United States?

Yes. FDA authorised it on 19 December 2019; FDA authorised it on 24 January 2023; FDA authorised it on 31 August 2023.

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

WATSON LABS TEVA holds the US marketing authorisation.