🇺🇸 temozolomide or PCV 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 temozolomide or PCV on 27 October 2025

Marketing authorisation

FDA — authorised 27 October 2025

Application: ANDA219265
Marketing authorisation holder: CARNEGIE
Local brand name: LOMUSTINE
Indication: CAPSULE — ORAL
Status: approved

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Frequently asked questions

Is temozolomide or PCV approved in United States?

Yes. FDA authorised it on 27 October 2025.

Who is the marketing authorisation holder for temozolomide or PCV in United States?

CARNEGIE holds the US marketing authorisation.