Zydus Lifesciences gets USFDA's nod to market generic version of Bortezomib

Zydus Lifesciences Ltd announced on Tuesday that the US Food and Drug Administration (USFDA) has given final approval to commercialize its generic version of Bortezomib for injection, which is used to treat certain types of cancer, as per PTI reported.

The USFDA has approved a single-dose vial of Bortezomib for injection with a strength of 3.5 mg per vial, according to a regulatory filing by the company.

According to PTI, Zydus Hospira in Gujarat will produce the medicine, which is a generic version of the reference listed drug Velcade.

Bortezomib injection is used to treat multiple myeloma and mantle cell lymphoma, among other cancers. According to the company, the medicine works by reducing or preventing the growth of cancer cells, said PTI.

Velcade has a market size of USD 1.172 billion, according to IQVIA MAT March 2022 statistics.

Since the commencement of the filing process in FY 2003-04, the company has received 331 approvals and filed over 400 ANDAs (abbreviated new drug applications), according to the filing.