Synokem Pharma Gets CDSCO Panel Nod to Study Dydrogesterone SR Tablet
New Delhi: The drug major Synokem Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to initiate Phase III clinical trial of Dydrogesterone sustained-release tablets (SR) Tablet 20mg.
This came after Synokem Pharmaceuticals presented the bioequivalence study report of Dydrogesterone sustained-release tablets 20mg before the committee.
Dydrogesterone is a progestogen (a synthetic form of progesterone hormone) used to treat progesterone deficiency (irregular periods, etc.) and other symptoms due to the increased activity of estrogen. It belongs to the 'hormonal replacement therapy' group of medicines.
Dydrogesterone helps to regulate the healthy growth and normal shedding of the uterus lining. Therefore, it may be useful in the treatment of menstrual disorders such as absent, irregular, or painful menstrual periods, infertility, premenstrual syndrome, and endometriosis.
Dydrogesterone is an orally active progestogen that acts directly on the uterus, producing a complete secretory endometrium in an estrogen-primed uterus. At therapeutic levels, dydrogesterone has no contraceptive effect as it does not inhibit or interfere with ovulation or the corpus luteum.
At the recent SEC meeting for Reproductive and Urology held on 20 September 2023, the expert panel reviewed the Bioequivalence study report of Dydrogesterone sustained-release tablets.
After detailed deliberation, the committee recommended for grant of permission to initiate Phase III clinical trial study as per Phase III clinical trial protocol approved vide clinical trial NOC dated 23.06.2023 for Dydrogesterone sustained release tablets 20mg.
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