🇺🇸 Durlaza™ in United States

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

FDA authorised Durlaza™ on 4 September 2015

Marketing authorisation

FDA — authorised 4 September 2015

Application: NDA200671
Marketing authorisation holder: HESP
Local brand name: DURLAZA
Indication: CAPSULE, EXTENDED RELEASE — ORAL
Status: approved

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Frequently asked questions

Is Durlaza™ approved in United States?

Yes. FDA authorised it on 4 September 2015.

Who is the marketing authorisation holder for Durlaza™ in United States?

HESP holds the US marketing authorisation.