FDA — authorised 4 August 2016
- Application: ANDA204285
- Marketing authorisation holder: TEVA PHARMS USA
- Indication: Labeling
- Status: approved
🇺🇸 IMATINIB in United States
FDA authorised IMATINIB on 4 August 2016 · 11,157 US adverse-event reports
Marketing authorisations
FDA — authorised 21 June 2017
- Application: ANDA204644
- Marketing authorisation holder: MYLAN
- Status: supplemented
FDA — authorised 17 January 2019
- Application: ANDA208429
- Marketing authorisation holder: CHARTWELL RX
- Status: approved
FDA — authorised 23 July 2020
- Application: ANDA212773
- Marketing authorisation holder: EUGIA PHARMA
- Status: supplemented
FDA — authorised 10 August 2020
- Application: NDA021588
- Marketing authorisation holder: NOVARTIS
- Indication: Labeling
- Status: approved
FDA — authorised 16 August 2023
- Application: ANDA206547
- Marketing authorisation holder: DR REDDYS
- Indication: Labeling
- Status: approved
FDA — authorised 22 November 2024
- Application: NDA219097
- Marketing authorisation holder: SHORLA ONCOLOGY
- Indication: Type 3 - New Dosage Form
- Status: approved
The FDA approved IMATINIB for a new dosage form on 22 November 2024. This approval was granted to SHORLA ONCOLOGY under the standard expedited pathway. The application number for this approval is NDA219097.
FDA — authorised 14 April 2025
- Application: ANDA212975
- Marketing authorisation holder: HETERO LABS LTD V
- 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: 11,157
Most-reported reactions
- Drug Ineffective — 1,720 reports (15.42%)
- Nausea — 1,400 reports (12.55%)
- Diarrhoea — 1,307 reports (11.71%)
- Death — 1,108 reports (9.93%)
- Drug Resistance — 1,091 reports (9.78%)
- Fatigue — 1,031 reports (9.24%)
- Drug Intolerance — 929 reports (8.33%)
- Vomiting — 897 reports (8.04%)
- Malignant Neoplasm Progression — 884 reports (7.92%)
- Off Label Use — 790 reports (7.08%)
IMATINIB 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 IMATINIB approved in United States?
Yes. FDA authorised it on 4 August 2016; FDA authorised it on 21 June 2017; FDA authorised it on 17 January 2019.
Who is the marketing authorisation holder for IMATINIB in United States?
TEVA PHARMS USA holds the US marketing authorisation.