Zydus Cadila receives USFDA approval for Fulvestrant Injection

Zydus Cadila receives USFDA approval for Fulvestrant Injection

Jul 30, 2021 12:07 IST capital market

Zydus Cadila has received final approval from the USFDA to market Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per Single-Dose Pre-filled Syringe (USRLD: Faslodex Injection).

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 groups formulation manufacturing facility at the Zydus Biologics, Ahmedabad.

The group now has 320 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.

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