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The contraceptive patch from Zydus Lifesciences has received final USFDA approval

Sep 18, 2023

By: BlinkX Research Team

The US Food and Drug Administration (USFDA) gave its final approval to Zydus Lifesciences Ltd.'s Norelgestromin and Ethinyl Estradiol Transdermal System on Friday. It is a skin patch that contains a mixture of hormone medications and is used to prevent pregnancy.

With its most recent approval, the pharmaceutical group now has 380 approvals and over 444 ANDAs filed for the fiscal years 2003–2004, according to the company.

According to Zydus Lifesciences, the Norelgestromin and Ethinyl Estradiol Transdermal System is the third hormonal transdermal patch approved by the USFDA from its generics portfolio.

The company's formulation manufacturing plant in Moraiya, Ahmedabad, Gujarat, will produce the contraceptive patch.

Norelgestromin and Ethinyl Estradiol Transdermal System, 150 mcg/35 mcg per day, had sales of $330 million per year in the US, according to IQVIA MAT data from July 2023.

On September 13, Zydus also announced that it had received the EIR report from the USFDA with no observations for the injectables production plant at the Changodar, Ahmedabad-based Zydus Biotech Park.

The USFDA inspected from June 5 to June 13, 2023.

Erythromycin Tablets USP 250 mg and 500 mg, used to prevent and treat infections in many different sections of the body, were also given final FDA approval this month, according to Zydus.

In the US, annual sales of erythromycin tablets, USP, 250 mg and 500 mg, were $23 million.