Zydus Cadila gets FDA OK for generic Doxil liposome injection

Patients with certain types of cancer will soon have a new generic treatment.

Zydus Cadila has received the Food and Drug Administration’s green light for doxorubicin hydrochloride liposome injection in dosage 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 that has been developed in house and will be manufactured at the group’s facility located in a special economic zone, or SEZ. 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.

Liposomal doxorubicin injection had a market value of approximately $124 million for the 12 months ended July 2020, according to IQVIA.

“This FDA approval of Liposomal Doxorubicin Injection demonstrates our long-term commitment to drive growth through investment in complex generic products" said Zydus' managing director, Sharvil Patel. "The approval further builds on Zydus’ proven track record of successfully commercializing and gaining meaningful market share in complex generics products, we expect our long-term investment reap dividends, as we create an industry-leading portfolio of complex products. Through this investment, we have created a diversified portfolio of complex ANDAs. This portfolio provides continued opportunities to grow our U.S. business in 2021 and beyond.”