Cipla launches Leuprolide Acetate Injection Depot 225mg

3 Dec 2022 , 01:34 AM

Cipla has launched Leuprolide Acetate Injection Depot 225mg The product was approved by the United States Food and Drug Administration US FDA based on a New Drug Application NDA submitted under the 505b2 regulatory pathway Leuprolide Acetate Injection Depot contains 225 mg of leuprolide acetate for 3-month administration given as a single dose injection It is supplied as lyophilized microspheres in a single dose vial as a kit with a prefilled syringe containing 2mL 08Percentage mannitol solution and an easy-to-use MIXJECT transfer device for a single dose injection It is indicated for palliative treatment of advanced prostate cancer The active ingredient route of administration dosage form and strength are the same as LUPRON DEPOT 225 mg strength from Abbvie According to IQVIA LUPRON DEPOT 225mg had US sales of approximately $197M for the 12-month period ending September 2022