Last Updated on January 9, 2024 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.
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.
SII gets CDSCO nod for Clinical Trial of reduced inactivated salk…
Lupin gets CDSCO committee nod for marketing Ranibizumab
40 Pharma Firms showed interest in anti Covid drug: DRDO
DRDO develops C-19 Antibody detection kit
CDSCO asks Philips India to discontinue these Ventilators
IPCA Lab gets CDSCO nod to conduct Phase-III study of HCQ
Procedure to obtain license for manufacturing of Medical Devices
6 reasons: How Gel creams are different from traditional cold creams
NPPA caps trade margin on Pulse Oximeter, Nebuliser, Digital Thermometer
Kerala to create an independent Drugs Control Administration for Ayurveda
Nutraceutical Industry: A trending Market
NPPA seeks details for 29 formulations from Drug Mfrs to fix…
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
