Sun Pharmaceutical Industries Gets CDSCO Panel Nod to Study FDC of Relugolix, Estradiol, Norethindrone Acetate
New Delhi: Rejecting for clinical trial waiver, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) opined the pharmaceutical major Sun Pharmaceutical Industries to conduct of Phase III clinical trial of the fixed-dose combination (FDC) of Relugolix, Estradiol and Norethindrone Acetate Tablets (40 mg + 1 mg + 0.5 mg) Tablets.
Relugolix is a gonadotropin-releasing hormone antagonist (GnRH receptor antagonist) medication that is used in the treatment of prostate cancer in men and uterine fibroids in women.
Estradiol is used for hormone replacement therapy and post-menopausal osteoporosis. Estradiol is an estrogen (female sex hormone). In women who are undergoing or have attained menopause, it prevents symptoms such as hot flashes, night sweats, and mood swings. It also prevents the bones from becoming porous and fragile (osteoporosis).
Norethisterone is a synthetic second-generation progestin used for contraception, prevention of endometrial hyperplasia in hormone replacement therapy, and in the treatment of other hormone-mediated illnesses such as endometriosis.
Also Read: Eli Lilly Gets CDSCO Panel Nod To Market Mirikizumab for ulcerative colitis in adults
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.