FDA — authorised 25 May 2022
- Application: ANDA202596
- Marketing authorisation holder: DR REDDYS
- Local brand name: PEMETREXED DISODIUM
- Indication: POWDER — INTRAVENOUS
- Status: approved
🇺🇸 pemetrexed plus cisplatin or carboplatin in United States
FDA authorised pemetrexed plus cisplatin or carboplatin on 25 May 2022
Marketing authorisations
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: ANDA209085
- Marketing authorisation holder: APOTEX
- 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: ANDA208696
- Marketing authorisation holder: JIANGSU HANSOH PHARM
- 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 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
- Status: approved
pemetrexed plus cisplatin or carboplatin 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 plus cisplatin or carboplatin 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 plus cisplatin or carboplatin in United States?
DR REDDYS holds the US marketing authorisation.