Drug firm Zydus Cadila on Friday said it has received final approval from the US health regulator to market Fulvestrant Injection, used in the treatment of breast cancer.
Fulvestrant injection is used alone or in combination with other drugs to treat a certain type of hormone receptor positive, advanced breast cancer (breast cancer that depends on hormones such as estrogen to grow) or breast cancer that has spread to other parts of the body in women who have experienced menopause.
Zydus Cadila has received final approval from the US Food and Drug Administration (USFDA) to market Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per single-dose pre-filled syringe, the company said in a statement. Zydus Cadila said the drug will be manufactured at the group’s formulation manufacturing facility at Zydus Biologics, Ahmedabad.
The group now has 320 approvals and has so far filed over 400 abbreviated new drug applications (ANDAs) since the commencement of the filing process in FY 2003-04.