Lupin & ForDoz Receives FDA Approval for Doxorubicin Liposome Injection

Lupin Limited, a prominent global pharmaceutical company, announced that its partner, ForDoz Pharma Corporation in the USA, has secured approval from the U.S. FDA for their Abbreviated New Drug Application. This approval pertains to the Doxorubicin Hydrochloride Liposome Injection, available in 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) single-dose vials, which will be marketed as a generic alternative to Baxter Healthcare Corporation’s Doxil® Liposome Injection. These injections, intended for the treatment of ovarian cancer, AIDS-related Kaposi’s Sarcoma, and multiple myeloma, had an estimated annual sales figure of USD 42 million in the U.S. as of May 2024, according to IQVIA.

Lupin, headquartered in Mumbai, India, is a pioneering global pharmaceutical company. It specializes in the development and commercialization of a diverse portfolio, including branded and generic drugs, biotechnology products, and active pharmaceutical ingredients (APIs). Lupin operates in over 100 markets, including the U.S., India, South Africa, and regions in the Asia Pacific (APAC), Latin America (LATAM), Europe, and the Middle East.

The company holds a leading position in the cardiovascular, anti-diabetic, and respiratory sectors and has a strong presence in the anti-infective, gastrointestinal (GI), central nervous system (CNS), and women’s health areas. Notably, Lupin is the third-largest pharmaceutical company in the U.S. by prescription volume. In FY24, the company allocated 7.8% of its revenue to research and development.