Drug agency Zydus Cadila on Friday mentioned it has acquired closing nod from the US well being regulator to market its generic Doxorubicin Hydrochloride Liposome injection, used for treatment of sure varieties of cancer, within the American market. The firm has acquired closing approval from the United States Food and Drug Administration (USFDA) to market Doxorubicin Hydrochloride Liposome injection within the strengths of 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) single-dose vials, Zydus Cadila mentioned in an announcement.
This is the group’s first approval for a posh injectable which has been developed in-house and will likely be manufactured on the group’s facility, it added.
According to IQVIA, the US gross sales for Liposomal Doxorubicin injection have been roughly USD 124 million (about Rs 910 crore) for the 12 months ending July 2020, Zydus Cadila mentioned.
“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 mentioned.
“Through this investment, we have created a diversified portfolio of complex abbreviated new drug applications (ANDAs). This portfolio provides continued opportunities to grow our US business in 2021 and beyond,” he added.
Liposomal Doxorubicin is a chemotherapeutic agent that’s used alone or with different remedies/drugs to deal with sure varieties of cancer comparable to ovarian cancer, AIDS-related Kaposi’s sarcoma and a number of myeloma.
It works by slowing or stopping cancer cell progress, the assertion mentioned.
The group now has 300 approvals and has to this point filed over 390 ANDAs because the graduation of its submitting course of, it added.
Shares of Cadila Healthcare, the listed entity of the group, closed 1.73 per cent larger at Rs 369.95 per scrip on the BSE.