FDA — authorised 25 May 2022
- Application: ANDA204890
- Marketing authorisation holder: QILU PHARM HAINAN
- Status: approved
🇺🇸 PEMETREXED DISODIUM in United States
FDA authorised PEMETREXED DISODIUM on 25 May 2022 · 1,977 US adverse-event reports
Marketing authorisations
FDA — authorised 25 May 2022
- Application: ANDA211899
- Marketing authorisation holder: RELIANCE LIFE
- Status: approved
FDA — authorised 25 May 2022
- Application: ANDA202596
- Marketing authorisation holder: DR REDDYS
- Status: supplemented
FDA — authorised 29 February 2024
- Application: ANDA209851
- Marketing authorisation holder: APOTEX
- Indication: Labeling
- Status: approved
The FDA approved PEMETREXED DISODIUM, a generic version of the cancer medication, on 29 February 2024. The approval was granted to APOTEX under the standard expedited pathway. The drug is indicated for use in the treatment of various cancers, as specified in the labelling.
FDA — authorised 29 February 2024
- Application: ANDA203774
- Marketing authorisation holder: APOTEX
- Indication: Labeling
- Status: approved
The FDA approved PEMETREXED DISODIUM, a generic version of the cancer medication, on 29 February 2024. The approval was granted to APOTEX through a standard application process. The drug is indicated for use in the treatment of various cancers, as stated in the labelling.
FDA — authorised 14 June 2024
- Application: ANDA215460
- Marketing authorisation holder: HETERO LABS LTD VI
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 1,977
Most-reported reactions
- Malignant Neoplasm Progression — 392 reports (19.83%)
- Myelosuppression — 347 reports (17.55%)
- Anaemia — 192 reports (9.71%)
- Diarrhoea — 177 reports (8.95%)
- Nausea — 171 reports (8.65%)
- Death — 148 reports (7.49%)
- Neutropenia — 140 reports (7.08%)
- Platelet Count Decreased — 138 reports (6.98%)
- Rash — 138 reports (6.98%)
- Febrile Neutropenia — 134 reports (6.78%)
PEMETREXED DISODIUM 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 DISODIUM approved in United States?
Yes. FDA authorised it on 25 May 2022; FDA authorised it on 25 May 2022; FDA authorised it on 25 May 2022.
Who is the marketing authorisation holder for PEMETREXED DISODIUM in United States?
QILU PHARM HAINAN holds the US marketing authorisation.