FDA — authorised 15 May 1996
- Marketing authorisation holder: LILLY
- Status: approved
🇺🇸 Gemzar in United States
FDA authorised Gemzar on 15 May 1996
Marketing authorisations
FDA — authorised 15 May 1996
- Application: NDA020509
- Marketing authorisation holder: LILLY
- Local brand name: GEMZAR
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 December 2015
- Application: ANDA078759
- Marketing authorisation holder: TEYRO LABS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 5 January 2016
- Application: ANDA204520
- Marketing authorisation holder: GLAND
- Status: approved
FDA — authorised 3 October 2019
- Application: ANDA091365
- Marketing authorisation holder: DR REDDYS LABS LTD
- Indication: Labeling
- Status: approved
FDA — authorised 27 June 2025
- Application: NDA219920
- Marketing authorisation holder: AVYXA HOLDINGS
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
The FDA approved Gemzar, a new formulation or new manufacturer, for marketing in the United States on 27 June 2025. The marketing authorisation holder is AVYXA HOLDINGS. This approval was granted under the standard expedited pathway.
FDA — authorised 9 September 2025
- Application: NDA219683
- Marketing authorisation holder: JANSSEN BIOTECH
- Indication: Type 3 - New Dosage Form
- Status: approved
The FDA approved Gemzar, a new dosage form, for marketing by Janssen Biotech on 9 September 2025. This approval was granted under the standard expedited pathway. The application number for this approval is NDA219683.
FDA
- Application: ANDA078460
- Marketing authorisation holder: EUROHLTH INTL
- Local brand name: GEMCITABINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA090644
- Marketing authorisation holder: TEVA PARENTERAL
- Local brand name: GEMCITABINE
- Indication: INJECTABLE — INJECTION
- Status: approved
Gemzar 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 Gemzar approved in United States?
Yes. FDA authorised it on 15 May 1996; FDA authorised it on 15 May 1996; FDA authorised it on 2 December 2015.
Who is the marketing authorisation holder for Gemzar in United States?
LILLY holds the US marketing authorisation.