Zydus Cadila gets final approval from USFDA for Fulvestrant Injection
30th Jul 2021

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 group’s 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.

Cadila Healthcare is an India-based pharmaceutical company. The company's subsidiaries include Zydus Wellness, Liva Pharmaceuticals, Biochem Pharmaceutical Industries, Zydus Technologies, German Remedies, Dialforhealth India, Dialforhealth Unity and Dialforhealth Greencross, among others.