Mumbai, India & Warren, NJ, USA: November 29, 2022: Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as “Cipla”) and its wholly owned subsidiary Cipla USA Inc., (hereafter referred to as “Cipla”), today announced the launch of Leuprolide Acetate Injection Depot 22.5mg. The product was approved by the United States Food and Drug Administration (“US FDA”) 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. 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 palliative treatment of advanced prostate cancer.
Arunesh Verma, CEO – Cipla North America, said, “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.”
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.