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.
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.
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