Sun Pharma Gets CDSCO Panel Go-Ahead to Manufacture, Market Relugolix, Estradiol, Norethindrone Acetate FDC
New Delhi: The Subject Expert Committee (SEC) under the Reproductive division of the Central Drugs Standard Control Organization (CDSCO) has recommended the grant of permission for the manufacturing and marketing of a Fixed Dose Combination (FDC) of Relugolix 40 mg, Estradiol 1 mg, and Norethindrone Acetate 0.5 mg tablets by Sun Pharmaceutical Industries Limited.
The proposal was reviewed during the SEC (Reproductive) meeting held on 19th June 2025 at CDSCO Headquarters, New Delhi. The firm presented its Phase III clinical trial report, as per the committee’s earlier recommendation dated 20th March 2024.
This three-drug oral combination is designed to treat hormone-dependent gynecological conditions such as uterine fibroids and endometriosis, where suppression of estrogen plays a key therapeutic role. Relugolix, a non-peptide oral GnRH receptor antagonist, reduces secretion of LH and FSH from the pituitary gland, thereby suppressing ovarian hormone production and alleviating symptoms linked to estrogen-sensitive disorders.
However, estrogen suppression can cause unwanted side effects like hot flashes, sweating, and mood changes. To address this, Estradiol is included in the formulation to manage vasomotor symptoms and provide hormonal balance. Norethindrone Acetate adds progestin support, mitigating the risk of endometrial hyperplasia associated with unopposed estrogen therapy.
After detailed deliberation, the SEC recommended the following;
“The committee recommended for the grant of permission for manufacturing and marketing of drug FDC of Relugolix, Estradiol and Norethindrone Acetate Tablets (40 mg + 1 mg + 0.5 mg).”
