Zydus Lifesciences gets FDA approval for Estradiol Transdermal System

Zydus Lifesciences (previously Cadila Healthcare) has secured final approval for 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 from the US Food and Drug Administration (FDA).

The approved product is a generic version of Vivelle-Dot Transdermal System.

Estradiol Transdermal System has FDA approval for the treatment of moderate to severe symptoms of menopause. The symptoms include feelings of warmth in the face, chest, or neck, or sudden strong feelings of heat, vaginal dryness, and hot flashes in women.

Zydus Lifesciences plans to manufacture the drug at its formulation manufacturing plant in Moraiya, Ahmedabad.

The Indian pharma company has taken its approvals count to 336 and to date has filed more than 431 abbreviated new drug applications (ANDAs) since the start of the filing process in FY 2003-04.