Cipla Limited on Monday announced the launch of Leuprolide Acetate Injection Depot 22.5mg. The product was approved by the United States Food and Drug Administration (USFDA) based on a New Drug Application (NDA) submitted under the 505(b)(2) regulatory pathway.
Leuprolide Acetate Injection Depot contains 22.5 mg of leuprolide acetate for 3-month administration given as a single dose injection.
According to the pharma major, it is supplied as lyophilized microspheres in a single dose vial as a kit with a prefilled syringe containing 2mL 0.8% mannitol solution and an easy-to-use MIXJECT transfer device for a single dose injection.
It is indicated for the palliative treatment of advanced prostate cancer. It is also indicated for endometriosis and used with other medication to treat anemia caused by uterine fibroids.
“The launch of Leuprolide Acetate Injection Depot reinforces our commitment as an organization to bring high quality and affordable treatments to patients in the US. Enabling access to high-quality treatments is core to our purpose of “Caring for Life”. This launch aligns with our strategy for growth in the complex product segment,” Arunesh Verma, CEO – Cipla North America, said in a statement.
According to Cipla, the active ingredient, route of administration, dosage form and strength are the same as LUPRON DEPOT 22.5 mg strength, from Abbvie.
According to IQVIA, LUPRON DEPOT 22.5mg had US sales of approximately $197M for the 12-month period ending September 2022.