FDA — authorised 8 February 2020
- Application: NDA209472
- Marketing authorisation holder: EAGLE PHARMS
- Local brand name: PEMFEXY
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 Standard of care neoadjuvant therapy in United States
FDA authorised Standard of care neoadjuvant therapy on 8 February 2020
Marketing authorisations
FDA — authorised 21 August 2020
- Application: NDA208419
- Marketing authorisation holder: ACTAVIS
- Local brand name: PEMETREXED
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 22 May 2023
- Application: NDA215179
- Marketing authorisation holder: SHILPA
- Local brand name: PEMETREXED
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA
- Application: ANDA090352
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: PEMETREXED
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: NDA208297
- Marketing authorisation holder: DR REDDYS LABS INC
- Local brand name: PEMETREXED FOR INJECTION
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA208927
- Marketing authorisation holder: BIOCON LTD
- Local brand name: PEMETREXED
- Indication: INJECTABLE — INJECTION
- Status: approved
Standard of care neoadjuvant therapy 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 Standard of care neoadjuvant therapy approved in United States?
Yes. FDA authorised it on 8 February 2020; FDA authorised it on 21 August 2020; FDA authorised it on 22 May 2023.
Who is the marketing authorisation holder for Standard of care neoadjuvant therapy in United States?
EAGLE PHARMS holds the US marketing authorisation.