Zydus Lifesciences gets USFDA nod for generic female hormone in US market
Zydus Lifesciences on Tuesday said it has received approval from the US regulator to market a generic female hormone, which helps reduce symptoms of menopause, in the US market.
The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Estradiol Transdermal System USP in the American market.
Estradiol transdermal system is indicated for prevention of postmenopausal osteoporosis.
The company said the drug will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad in Gujarat.
As per the IQVIA sales data, Estradiol Transdermal System had annual sales of USD 1.9 million in the US.