FDA — authorised 25 May 2022
- Application: ANDA209851
- Marketing authorisation holder: APOTEX
- Local brand name: PEMETREXED DISODIUM
- Indication: POWDER — INTRAVENOUS
- Status: approved
🇺🇸 Pemetrexed Disodium for Injection in United States
FDA authorised Pemetrexed Disodium for Injection on 25 May 2022 · 10 US adverse-event reports
Marketing authorisations
FDA — authorised 25 May 2022
- Application: ANDA208696
- Marketing authorisation holder: JIANGSU HANSOH PHARM
- Local brand name: PEMETREXED DISODIUM
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 25 May 2022
- Application: ANDA202596
- Marketing authorisation holder: DR REDDYS
- Local brand name: PEMETREXED DISODIUM
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 25 May 2022
- Application: ANDA214073
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: PEMETREXED DISODIUM
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 25 May 2022
- Application: ANDA209085
- Marketing authorisation holder: APOTEX
- Local brand name: PEMETREXED DISODIUM
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 25 May 2022
- Application: ANDA203774
- Marketing authorisation holder: APOTEX
- Local brand name: PEMETREXED DISODIUM
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 25 May 2022
- Application: ANDA204890
- Marketing authorisation holder: QILU PHARM HAINAN
- Local brand name: PEMETREXED DISODIUM
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 25 May 2022
- Application: ANDA211899
- Marketing authorisation holder: RELIANCE LIFE
- Local brand name: PEMETREXED DISODIUM
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 25 May 2022
- Application: ANDA207352
- Marketing authorisation holder: NANG KUANG PHARM CO
- Local brand name: PEMETREXED DISODIUM
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 25 May 2022
- Application: ANDA202111
- Marketing authorisation holder: HOSPIRA
- Local brand name: PEMETREXED DISODIUM
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 25 May 2022
- Application: ANDA214632
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: PEMETREXED DISODIUM
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 25 May 2022
- Application: ANDA211090
- Marketing authorisation holder: BIOCON PHARMA
- Local brand name: PEMETREXED DISODIUM
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 22 June 2022
- Application: NDA214218
- Marketing authorisation holder: HOSPIRA
- Local brand name: PEMETREXED DISODIUM
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 19 July 2022
- Application: NDA214408
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: PEMETREXED DISODIUM
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 4 August 2022
- Application: ANDA210047
- Marketing authorisation holder: AMNEAL
- Local brand name: PEMETREXED DISODIUM
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 18 August 2022
- Application: ANDA214436
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Local brand name: PEMETREXED DISODIUM
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 10 March 2023
- Application: ANDA203628
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: PEMETREXED DISODIUM
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 11 December 2023
- Application: ANDA216582
- Marketing authorisation holder: PRINSTON INC
- Local brand name: PEMETREXED DISODIUM
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 14 June 2024
- Application: ANDA215460
- Marketing authorisation holder: HETERO LABS LTD VI
- Local brand name: PEMETREXED DISODIUM
- Indication: POWDER — INTRAVENOUS
- 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: 23 April 2025 – 23 April 2026
- Total reports: 10
Most-reported reactions
- Cerebrovascular Accident — 1 report (10%)
- Febrile Neutropenia — 1 report (10%)
- Hepatic Function Abnormal — 1 report (10%)
- Immune System Disorder — 1 report (10%)
- Myelosuppression — 1 report (10%)
- Oral Mucosal Exfoliation — 1 report (10%)
- Platelet Count Decreased — 1 report (10%)
- Rash — 1 report (10%)
- Rash Erythematous — 1 report (10%)
- Rash Pruritic — 1 report (10%)
Other Oncology approved in United States
Frequently asked questions
Is Pemetrexed Disodium for Injection 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 for Injection in United States?
APOTEX holds the US marketing authorisation.