Zydus Lifesciences’ Menostar Transdermal System generic gets FDA final approval

Zydus Lifesciences has secured final approval from the UA Food and Drug Administration (FDA) for Estradiol Transdermal System USP, 0.014 mg/day.

The approved product which is to be used weekly is the generic version of Menostar Transdermal System and is approved for preventing postmenopausal osteoporosis.

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

Zydus Lifesciences’ Estradiol Transdermal System gets FDA final approval. Photo courtesy of Zydus Cadila.

As per IQVIA MAT Feb. 2023, the annual sales of Estradiol Transdermal System USP, 0.014 mg/day (weekly) was $1.9 million.

Zydus Lifesciences now has 363 approvals and has filed more than 440 abbreviated new drug applications (ANDAs) so far since the start of the filing process in FY 2003-04.

In late 2022, Zydus Lifesciences was granted 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 FDA.