Cipla Limited and its wholly owned subsidiary, Cipla USA Inc., launched Leuprolide Acetate Injection Depot 22.5 mg. The injection was approved by the US Food and Drug Administration based on a New Drug Application (NDA) submitted under the regulatory pathway 505(b)(2).
According to Cipla, Leuprolide Acetate Injection Depot contains 22.5 mg of leuprolide acetate for administration as a single dose injection. The injection 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 MIXJECT transfer device for a single dose injection.
The injection is indicated for treating advanced prostate cancer. Arunesh Verma, chief executive officer at Cipla North America said that, the launch of Leuprolide Acetate Injection Depot reinforces their commitment as an organization to bring high quality and low cost treatments to patients in the United States.
Enabling access to some high-quality treatments is core to their purpose of Caring for Life, and this launch aligns with their strategy for growth in the complex product segment, says Arunesh Verma.
The active ingredient, dosage form, route of administration, and strength are the same as those of LUPRON DEPOT 22.5 mg strength produced by Abbvie. According to IQVIA, the total sales of LUPRON DEPOT 22.5mg was around 197 million dollars in the US for the period of 12 months period ending September 2022.