Sun Pharmaceutical Industries Gets CDSCO Panel Nod to Study FDC of Relugolix, Estradiol, Norethindrone Acetate

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-04-08T18:00:59+05:30 | Updated On 8 April 2024 6:00 PM IST

Sun Pharma slapped Rs 76 crore fine by customs authorities

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.

This came after the drug major Sun Pharmaceutical Industries presented the proposal before the committee for CT waiver and the published safety and efficacy data.

The committee did not agree to the clinical trial waiver and the firm was asked to present Phase III CT protocol in continuation with an earlier SEC recommendation dated 19th December 2023.

In continuation with the above, the committee recommended for conducting the Phase III clinical trial as per the protocol presented by the firm.

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.

At the recent SEC meeting for the Reproductive held on 20th March 2024, the expert panel reviewed the proposal presented by the drug major Sun Pharmaceutical Industries regarding the FDC Relugolix, Estradiol, and Norethindrone Acetate Tablets.

After detailed deliberation, the committee recommended the conducting of a Phase III clinical trial as per the protocol presented by the firm.

Also Read: Eli Lilly Gets CDSCO Panel Nod To Market Mirikizumab for ulcerative colitis in adults

Sun Pharmaceutical Industriessun pharmacdscorelugolixestradiolnorethindrone acetatefdc

Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751