United States Food and Drug Administration (USFDA) has given Zydus Lifesciences Limited (formerly Cadila Healthcare Limited) final approval 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.
The Estradiol Transdermal System is used to treat moderate to severe menopausal symptoms such as feelings of warmth in the face, neck, and chest, as well as sudden strong feelings of heat, hot flushes, and vaginal dryness in women. The drug will be manufactured in Moraiya, Ahmedabad, India, at the group’s formulation manufacturing facility.
Since the beginning of the filing process in FY 2003-04, the group has so far received 336 approvals and has filed over 431 ANDAs.
At around 2.12 PM, Zydus Lifesciences was trading at Rs413.80 up by 0.61% from its previous closing of Rs411.30 on the BSE. The scrip touched intraday high and low of Rs413.95 and Rs408.80 respectively.
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