Zydus Lifesciences secures USFDA approval for Estradiol Transdermal System to treat menopause symptoms
Ahmedabad: Pharma major Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited) has announced that the company 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.
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.
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Zydus Lifesciences Limited, formerly Cadila Healthcare Limited, is an Indian multinational pharmaceutical company headquartered in Ahmedabad. The company is primarily engaged in the manufacture of generic drugs. Zydus group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh, and Sikkim in India and in the US and Brazil.
Zydus' global business has a strong presence in the regulated markets of the US, Europe (France and Spain), and the high-profile markets of Latin America and South Africa. It is also present in a big way in 25 other emerging markets worldwide.
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