Zydus Cadila gets USFDA nod to market its cancer treatment injection

This is the group’s first approval for a complex injectable which has been developed in-house and will be manufactured at the group’s facility, an official statement from the company said.

MUMBAI: 05/06/2013: (left) Pankaj R. Patel, Chairman & Managing Director, Zybus Cadila and Sharvil P. Patel, Deputy Managing Director at a press conference in Mumbai on June 5, 2013. Photo: Shashi Ashiwal

Drug firm Zydus Cadila on Friday said it has received final nod from the U.S. health regulator to market its generic Doxorubicin Hydrochloride Liposome injection, used for treatment of certain types of cancer, in the American market.

The company has received final approval from the United States Food and Drug Administration (USFDA) to market Doxorubicin Hydrochloride Liposome injection in the strengths of 20mg/10mL (2 mg/mL) and 50mg/25mL (2mg/mL) single-dose vials, Zydus Cadila said in a statement.

This is the group’s first approval for a complex injectable which has been developed in-house and will be manufactured at the group’s facility, it added.

According to IQVIA, the U.S. sales for Liposomal Doxorubicin injection were approximately USD 124 million (about ₹910 crore) for the 12 months ending July 2020, Zydus Cadila said.

“This FDA approval of Liposomal Doxorubicin injection demonstrates our long-term commitment to drive growth through investment in complex generic products,” Zydus Cadila MD Sharvil Patel said.

“Through this investment, we have created a diversified portfolio of complex abbreviated new drug applications (ANDAs). This portfolio provides continued opportunities to grow our U.S. business in 2021 and beyond,” he added.

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 statement said.

The group now has 300 approvals and has so far filed over 390 ANDAs since the commencement of its filing process, it added. Shares of Cadila Healthcare, the listed entity of the group, closed 1.73% higher at ₹369.95 per scrip on the BSE.