Zydus bags final USFDA approval for Estradiol Transdermal System

Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Estradiol Transdermal System USP, 0.014 mg/day, the company announced on Tuesday.

According to the regulatory filing, Estradiol transdermal system is indicated for prevention of postmenopausal osteoporosis. 

The drug will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad (India), the company said.

Further, Estradiol Transdermal System USP, 0.014 mg/day (weekly) had annual sales of USD 1.9 million in the United States, as per IQVIA MAT Feb. 2023.

The group now has 363 approvals and has so far filed over 440 ANDAs since the commencement of the filing process in FY 2003-04.

Source: Media reports