Zydus Gets Final Approval For A Hormonal Transdermal Patch From USFDA

Ahmedabad-based Zydus Lifesciences has received final approval from the US Food and Drug Administration (USFDA) for Norelgestromin and Ethinyl Estradiol Transdermal system, 150mcg /35mcg per day, the company said in an exchange filing on Friday.

Norelgestromin and Ethinyl Estradiol Transdermal system is a hormonal transdermal patch that contains a combination of hormone medication and is used to prevent pregnancy. This will be the third hormonal transdermal patch to be approved from Zydus’ generic portfolio.

This transdermal patch will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad. According to IQVIA MAT July 2023 data Norelgestromin and Ethinyl Estradiol Transdermal system had annual sales of USD 330 million in the United States.

The company currently has 380 approvals and has filed for over 444 ANDAs by 30th June 2023 since the commencement of the filing process in FY2003-04.