🇺🇸 PEMETREXED DIPOTASSIUM in United States

FDA authorised PEMETREXED DIPOTASSIUM on 28 June 2024

Marketing authorisation

FDA — authorised 28 June 2024

Application: NDA210661
Marketing authorisation holder: AVYXA HOLDINGS
Local brand name: AXTLE
Indication: POWDER — INTRAVENOUS
Status: approved

The FDA approved PEMETREXED DIPOTASSIUM for its labelled indication on 18 June 2025. The marketing authorisation holder is AVYXA HOLDINGS. The application number for this approval is NDA210661. This approval was granted under the standard expedited pathway.

Read official source →

PEMETREXED DIPOTASSIUM in other countries

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

Frequently asked questions

Is PEMETREXED DIPOTASSIUM approved in United States?

Yes. FDA authorised it on 28 June 2024.

Who is the marketing authorisation holder for PEMETREXED DIPOTASSIUM in United States?

AVYXA HOLDINGS holds the US marketing authorisation.