Cipla gains on launching US FDA-approved prostate cancer treatment drug

29 Nov 2022 , 09:21 AM

The 505(b)(2) regulatory pathway is another type of new drug application (NDA) submission that can be used to obtain the approval of a new drug. This type of submission differs from the 505(b)(1) NDA in that the product in question contains similar active ingredients to a previously approved drug. Sponsors taking advantage of the 505(b)(2) regulatory pathway can experience a shorter drug development program that requires fewer resources than the traditional regulatory pathway for obtaining drug approvals from the United States Food and Drug Administration (US FDA). The active ingredient, route of administration, dosage form and strength are the same as LUPRON DEPOT 22.5 mg strength, from Abbvie,? Cipla said in a statement. Leuprolide Acetate Injection Depot contains 22.5 mg of leuprolide acetate for 3- month administration given as a single dose injection. It is indicated for palliative treatment of advanced prostate cancer. According to IQVIA, LUPRON DEPOT 22.5mg had US sales of approximately $197 million for the 12-month period ending September 2022. 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.? Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in our home markets of India, South Africa, North America, and key regulated and emerging markets. The pharma majors consolidated net profit rose 10.9% to Rs 788.90 crore on 5.59% increase in total revenue from operations to Rs 5,828.54 crore in Q2 FY23 over Q2 FY22. Powered by Capital Market – Live News