Zydus Cadila receives final approval from US FDA for Fulvestrant injection

Zydus Cadila has received the final approval from the US Food and Drug Administration (FDA) to market Fulvestrant injection, 250 mg/5 mL per Single-Dose Pre-filled Syringe (USRLD: Faslodex injection), a statement from Zydus said.

It also said that the (50 mg/mL) 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.

The drug will be manufactured at the group’s formulation manufacturing facility at the Zydus Biologics, Ahmedabad, the statement added.