Research & Development
Cipla Limited and Cipla USA launch Leuprolide Acetate Injection Depot 22.5mg
30 November 2022 -

Cipla Limited (BSE: 500087) (NSE: CIPLA EQ), an India-based pharmaceutical company, and its wholly owned subsidiary Cipla USA Inc., announced on Tuesday the launch of Leuprolide Acetate Injection Depot 22.5mg.

The United States Food and Drug Administration (FDA) approved the product based on a New Drug Application (NDA) submitted under the 505(b)(2) regulatory pathway.

Leuprolide Acetate Injection Depot contains 22.5mg of leuprolide acetate for 3-month administration given as a single dose injection. It is supplied as lyophilised microspheres in a single dose vial as a kit with a prefilled syringe that includes 2mL 0.8% mannitol solution and MIXJECT transfer device for a single dose injection. It is a palliative treatment of advanced prostate cancer.