Zydus Cadila gets US FDA approval for Doxorubicin Hydrochloride Liposome Injection

Zydus Cadila has received final approval from the USFDA to market Doxorubicin Hydrochloride Liposome Injection (US RLD: Doxil Liposome Injection) in the strengths of 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) Single-Dose Vials.

“This is the group’s first approval for a complex injectable which has been developed in-house and will be manufactured at group’s facility located in SEZ. The company’s injectable portfolio has 39 products under development with an addressable market size of $20 billion,” informs a statement from the company.

US sales for Liposomal Doxorubicin Injection were approximately $124 million for the 12 months ending July 2020, according to IQVIA.

Speaking on the development, Dr Sharvil Patel, MD, Zydus Cadila said, “This FDA approval of Liposomal Doxorubicin Injection demonstrates our long-term commitment to drive growth through investment in complex generic products. Through this investment, we have created a diversified portfolio of complex ANDAs. This portfolio provides continued opportunities to grow our US business in 2021 and beyond.”

Liposomal doxorubicin is a chemotherapeutic agent that is used alone or with other treatments/medications to treat certain types of cancer such as ovarian cancer, AIDS-related Kaposi’s sarcoma and multiple myeloma. It works by slowing or stopping cancer cell growth.

The group now has 300 approvals and has so far filed over 390 ANDAs since the commencement of the filing process in FY 2003-04.