USFDA nod to Zydus Lifesciences Estradiol Transdermal System for postmenopausal osteoporosis prevention

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

Published On 2023-04-19 06:02 GMT   |   Update On 2023-04-19 06:04 GMT
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Ahmedabad: Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Estradiol Transdermal System USP, 0.014 mg/day (weekly) (USRLD: Menostar Transdermal System).

Estradiol transdermal system is indicated for prevention of postmenopausal osteoporosis.

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

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Estradiol Transdermal System USP, 0.014 mg/day (weekly) had annual sales of USD 1.9 mn in the United States (IQVIA MAT Feb. 2023). The group now has 363 approvals and has so far filed over 440* ANDAs since the commencement of the filing process in FY 2003-04.

Read also: Zydus Lifesciences bags USFDA okay for Isoproterenol Hydrochloride Injection

Zydus Lifesciences Limited (Formerly known as Cadila Healthcare Limited), an Indian Pharmaceutical company is a fully integrated, global healthcare provider. The company was founded in the year 1952 by Mr. Ramanbhai B. Patel (late), a first-generation entrepreneur and a doyen in the field of Indian Pharmaceuticals.

Read also: USFDA approves Zydus Lifesciences Tavaborole Topical Solution to treat fungal toenail infections




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