Zydus Lifesciences gets USFDA nod for Estradiol Transdermal system

The drug maker on Friday (2 December 2022) announced that it has received a final approval from the United States Food and Drug Administration (USFDA) to market Estradiol Transdermal system USP.

Estradiol Transdermal system is indicated to treat moderate to severe symptoms of menopause which includes feelings of warmth in the face, neck and chest or sudden strong feelings of heat, hot flushes and vaginal dryness in women.

The pharmaceutical company said that the drug will be manufactured at the group's formulation manufacturing facility at Moraiya, Ahmedabad, India.

Estradiol Transdermal system is a generic equivalent of Vivelle-Dot Transdermal system.

The group now has 336 approvals and has so far filed over 431 ANDAs since the commencement of the filing process in FY 2003-04, the drug maker stated.

Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

The company's consolidated net profit slumped 82.6% to Rs 522.50 crore despite of a 10% increase in total revenue from operations to Rs 4,134.7 crore in Q2 FY23 over Q2 FY22.

Shares of Zydus Lifesciences were down 0.21% to Rs 410.45 on the BSE.

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