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. 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. Also read | Vaccine for all: On COVID-19 vaccine policyThe group now has 300 approvals and has so far filed over 390 ANDAs since the commencement of its filing process, it added.
Source: The Hindu September 11, 2020 11:15 UTC