FDA — authorised 8 February 2020
- Application: NDA209472
- Marketing authorisation holder: EAGLE PHARMS
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
🇺🇸 Alimta in United States
FDA authorised Alimta on 8 February 2020
Marketing authorisations
FDA — authorised 25 May 2022
- Application: ANDA204890
- Marketing authorisation holder: QILU PHARM HAINAN
- Status: approved
FDA — authorised 22 November 2022
- Application: NDA208419
- Marketing authorisation holder: ACTAVIS
- Indication: Efficacy
- Status: approved
FDA — authorised 29 February 2024
- Application: ANDA209851
- Marketing authorisation holder: APOTEX
- Indication: Labeling
- Status: approved
The FDA approved Alimta for its labelled indication on 2024-02-29. This approval was granted to APOTEX under the standard expedited pathway. Alimta's application number is ANDA209851.
FDA — authorised 29 February 2024
- Application: ANDA203774
- Marketing authorisation holder: APOTEX
- Indication: Labeling
- Status: approved
The FDA approved Alimta for labeling indication by APOTEX on February 29, 2024. This approval was granted under the standard expedited pathway. Alimta is a drug product, but the local brand name is not reported.
Alimta in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Alimta approved in United States?
Yes. FDA authorised it on 8 February 2020; FDA authorised it on 25 May 2022; FDA authorised it on 22 November 2022.
Who is the marketing authorisation holder for Alimta in United States?
EAGLE PHARMS holds the US marketing authorisation.