FDA — authorised 18 April 2003
- Application: NDA021588
- Marketing authorisation holder: NOVARTIS
- Status: supplemented
🇺🇸 Gleevec in United States
FDA authorised Gleevec on 18 April 2003 · 15,106 US adverse-event reports
Marketing authorisations
FDA — authorised 3 December 2015
- Application: ANDA078340
- Marketing authorisation holder: SUN PHARM
- Local brand name: IMATINIB MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 August 2016
- Application: ANDA079179
- Marketing authorisation holder: APOTEX
- Local brand name: IMATINIB MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 July 2018
- Application: ANDA207586
- Marketing authorisation holder: HIKMA
- Local brand name: IMATINIB MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 January 2019
- Application: ANDA208302
- Marketing authorisation holder: SHILPA
- Local brand name: IMATINIB MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 February 2019
- Application: ANDA207495
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: IMATINIB MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 February 2019
- Application: ANDA205990
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: IMATINIB MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 March 2019
- Application: ANDA207818
- Marketing authorisation holder: NATCO PHARMA LTD
- Local brand name: IMATINIB MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 April 2020
- Application: ANDA210658
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: IMATINIB MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 July 2020
- Application: ANDA212773
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: IMATINIB MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 June 2022
- Application: ANDA212135
- Marketing authorisation holder: QILU PHARM HAINAN
- Local brand name: IMATINIB MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 April 2025
- Application: ANDA212193
- Marketing authorisation holder: CSPC OUYI
- Local brand name: IMATINIB MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- 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: 15,106
Most-reported reactions
- Death — 4,123 reports (27.29%)
- Nausea — 1,956 reports (12.95%)
- Diarrhoea — 1,592 reports (10.54%)
- Fatigue — 1,385 reports (9.17%)
- Drug Ineffective — 1,232 reports (8.16%)
- Vomiting — 1,185 reports (7.84%)
- Malaise — 1,004 reports (6.65%)
- Rash — 938 reports (6.21%)
- Dyspnoea — 855 reports (5.66%)
- Muscle Spasms — 836 reports (5.53%)
Gleevec 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 Gleevec approved in United States?
Yes. FDA authorised it on 18 April 2003; FDA authorised it on 3 December 2015; FDA authorised it on 5 August 2016.
Who is the marketing authorisation holder for Gleevec in United States?
NOVARTIS holds the US marketing authorisation.