Zydus Lifesciences receives USFDA approval for Estradiol Transdermal System

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to market Estradiol Transdermal System USP, 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day (USRLD: Vivelle-Dot Transdermal System).

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 drug will be manufactured at the group's formulation manufacturing facility at Moraiya, Ahmedabad, India.

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