Pharmaceutical maker Zydus Lifesciences Limited on Friday announced that it has received final approval from the United States Food and Drug Administration (USFDA) for Norelgestromin and Ethinyl Estradiol Transdermal System. The transdermal system contains a combination of hormone medication to prevent pregnancy.
The company said that this is the third hormonal transdermal patch to be approved from Zydus’ generics portfolio. The transdermal patch will be manufactured at the group’s manufacturing facility at Moraiya, Ahmedabad.
According to data released by IQVIA MAT, Norelgestromin and Ethinyl Estradiol Transdermal System had annual sales of $330 million in the United States.
Since the commencement of the filing process in the financial year 2003-04 (FY04), Zydus has had 380 approvals and has so far filed over 444 abbreviated new drug applications (ANDAs). Zydus Lifesciences reported a 109 per cent year-on-year (YoY) growth in net profit at Rs 1,086.9 crore in the first quarter of FY24. Revenue rose 29.6 per cent at Rs 5,139.6 crore.