United States Food and Drug Administration (USFDA) gave the green flag to Zydus Lifescience Limited to commercialize its generic version of Bortezomib. According to the reports, USFDA approved the final license to Zydus on Tuesday, 3rd May 2022. Bortezomib is an injection used to treat certain types of cancer.
According to a regulatory filing by the company, the USFDA has only allowed a single-dose vial of Bortezomib for injection. The strength of the dose must be 3.5 mg/vial. The drug, a generic version of the reference listed drug Velcade, will be manufactured by Zydus Hospira in Gujarat.
Bortezomib injection can treat multiple myeloma and mantle cell lymphoma. As per Zydus, the medicine toils its impact by reducing or preventing the growth of cancer cells. According to IQ VIA MAT March 2022, Velcade has a market size of USD 1.172 billion.
The beginning of the filing process started in 2003-04. Since then, Zydus has received 331 approvals and has filed over 400 ANDAs (abbreviated new drug applications).
Headquartered in Ahmedabad, India, Zydus was formerly known as Cadila Healthcare Limited. Established in 1988, this company ranks 4th in the Indian pharmaceutical industry and is spread across India, USA, and Brazil.