Zydus Lifesciences Ltd on Friday announced receiving final approval from the US Food and Drug Administration (USFDA) for Norelgestromin and Ethinyl Estradiol Transdermal System. It is a skin patch containing a combination hormone medication and is used to prevent pregnancy.
With the latest approval, the pharmaceutical group now has 380 approvals and has filed over 444 ANDAs FY2003-04, the company said.
Zydus Lifesciences said that Norelgestromin and Ethinyl Estradiol Transdermal System is the third hormonal transdermal patch from its generics portfolio that has received USFDA approval.
The contraceptive patch will be produced at the company’s formulation manufacturing facility at Moraiya in Ahmedabad, Gujarat.
According to IQVIA MAT July 2023 data, Norelgestromin and Ethinyl Estradiol Transdermal System, 150 mcg/35 mcg per day, had sales of $330 million annually in the US.
Zydus on September 13 had also announced receiving the EIR report from the USFDA for injectables manufacturing facility at Zydus Biotech Park located at Changodar, Ahmedabad will nil observations.
The inspection was conducted by the USFDA from 5th to 13th June, 2023.
Zydus this month also announced receiving final approval from the USFDA for Erythromycin Tablets USP 250 mg and 500 mg, used to prevent and treat infections in many different parts of the body.
Erythromycin Tablets USP, 250 mg and 500mg had annual sales of $23 million in the US.
(Edited by : Asmita Pant)
