🇺🇸 pentoxifylline (PTX) 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 pentoxifylline (PTX) on 30 August 1984

Marketing authorisation

FDA — authorised 30 August 1984

Application: NDA018631
Marketing authorisation holder: VALIDUS PHARMS
Local brand name: TRENTAL
Indication: TABLET, EXTENDED RELEASE — ORAL
Status: approved

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Frequently asked questions

Is pentoxifylline (PTX) approved in United States?

Yes. FDA authorised it on 30 August 1984.

Who is the marketing authorisation holder for pentoxifylline (PTX) in United States?

VALIDUS PHARMS holds the US marketing authorisation.