FDA — authorised 10 May 2001
- Application: NDA021335
- Marketing authorisation holder: NOVARTIS
- Local brand name: GLEEVEC
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Gleevec in United States
FDA authorised Gleevec on 10 May 2001
Marketing authorisations
FDA — authorised 10 May 2001
- Marketing authorisation holder: NOVARTIS
- Status: approved
FDA — authorised 18 April 2003
- Application: NDA021588
- Marketing authorisation holder: NOVARTIS
- Local brand name: GLEEVEC
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 January 2019
- Application: ANDA208429
- Marketing authorisation holder: CHARTWELL RX
- Status: approved
FDA — authorised 9 January 2020
- Application: ANDA204285
- Marketing authorisation holder: TEVA PHARMS USA
- 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 Gleevec, a medication developed by SHORLA ONCOLOGY, for a new dosage form on 22 November 2024. This approval was granted under the standard expedited pathway. The application number for this approval is NDA219097. Gleevec is indicated for the treatment of a specific condition, as classified under Type 3 - New Dosage Form.
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 10 May 2001; FDA authorised it on 10 May 2001; FDA authorised it on 18 April 2003.
Who is the marketing authorisation holder for Gleevec in United States?
NOVARTIS holds the US marketing authorisation.