Gujarat-based pharma giant Zydus Cadila has received final approval from the US Food and Drug Administration (USFDA) to market Fulvestrant injection, used in the treatment of breast cancer.
Zydus Cadila said this injection is either used alone or in combination with other drugs to treat certain types of advanced breast cancer cases.
Zydus will now market the jab as 250 mg/5 mL or 50 mg/mL as a single-dose in pre-filled syringes.
The injection will be used in breast cancer cases where tumours are dependant on hormones such as estrogen to grow, or in cases where the breast cancer has spread to other parts of the body in women who are post-menopausal.
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This injection will be manufactured at Zydus Cadila's formulation manufacturing facility at Zydus Biologics, Ahmedabad.