Abbott gets CDSCO nod for FDC of Dydrogesterone + Estradiol

The firm presented the trial data with respect to Asian population as per the recommendation of earlier SEC held on September 23, 2020.

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CDSCO FDA

Last Updated on July 17, 2021 by The Health Master

Abbott, the global healthcare company, has received approval from the Subject Expert Committee (SEC) at Central Drugs Standard Control Organisation (CDSCO) for importing and marketing of the fixed dose combination of dydrogesterone + estradiol (2.5 mg + 0.5mg) tablets.

The firm presented the trial data with respect to Asian population as per the recommendation of earlier SEC held on September 23, 2020.

After detailed deliberation, the committee considered phase III CT waiver and recommended for grant of permission for import and market of the subject FDC subject to the condition that the firm should submit the phase IV clinical trial protocol within 3 months of approval of the FDC.

Estradiol / dydrogesterone (E2/DYD), sold under the brand name Femoston among others, is a combination of estradiol (E2), an estrogen, and dydrogesterone (DYD), a progestin, which is used in menopausal hormone therapy, specifically to treat and prevent hot flashes and osteoporosis, in postmenopausal women.

Medicine Tablet
Picture: Pixabay

Estradiol, also spelled oestradiol, is an estrogen steroid hormone and the major female sex hormone. It is involved in the regulation of the estrous and menstrual female reproductive cycles.

Dydrogesterone is a progestin medication which is used for a variety of indications, including threatened or recurrent miscarriage during pregnancy dysfunctional bleeding, infertility due to luteal insufficiency, dysmenorrhea, endometriosis, secondary amenorrhea, irregular cycles, premenstrual syndrome, and as a component of menopausal hormone therapy.

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Its portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Its products encircle life, from newborns to aging adults, from nutrition and diagnostics through medical care and pharmaceutical therapy.

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