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  • MSN Lab gets CDSCO...

MSN Lab gets CDSCO Panel nod for phase III CT of Elagolix Tablets

Dr. Divya ColinWritten by Dr. Divya Colin Published On 2023-02-19T18:00:24+05:30  |  Updated On 19 Feb 2023 12:30 PM GMT
MSN Lab gets CDSCO Panel nod for phase III CT of  Elagolix Tablets
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New Delhi: The drug major MSN Laboratories has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the proposed Phase III clinical trial of the Elagolix Tablets 150mg & 200mg as per the protocol.This came in line with the proposal presented by the drug maker MSN Laboratories for grant of permission...

New Delhi: The drug major MSN Laboratories has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the proposed Phase III clinical trial of the Elagolix Tablets 150mg & 200mg as per the protocol.

This came in line with the proposal presented by the drug maker MSN Laboratories for grant of permission for manufacturing and marketing of the drug Elagolix Tablets 150mg & 200mg.

In addition, the drug maker MSN Laboratories has submitted the result of bioequivalence (BE) Study and Phase III clinical trial protocol before the committee.

Elagolix is a gonadotropin releasing hormone receptor antagonist used to treat moderate to severe pain in endometriosis.

Also Read:Sun Pharma Gets CDSCO Panel Nod To Study Elagolix tablet

Endometriosis develops when tissue that is similar to the kind that is normally located in the uterus starts to grow outside of the uterus. Such growth leads to various symptoms like pain during periods, pelvic pain between periods, and pain during sexual intercourse.

Elagolix is an orally-administered, nonpeptide small molecule gonadotropin-releasing hormone (GnRH) receptor antagonist that inhibits endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland.

Administration of elagolix results in dose-dependent suppression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), leading to decreased blood concentrations of the ovarian sex hormones, estradiol and progesterone.

At the recent SEC meeting for the Reproductive & Urology held on 31st January 2023, the expert panel reviewed the proposal for manufacturing and marketing the drug Elagolix Tablets 150mg & 200mg along with the result of BE Study and Phase III clinical trial protocol.
After detailed deliberation, the committee recommended the grant of permission to conduct the proposed Phase III clinical trial as per the protocol presented.

Also Read:Cadila Pharma gets CDSCO panel nod for Phase III CT Of Recombinant Rabies G Protein Vaccine

Elagolixmsn labs newsmsn labscdscoendometriosisPhase III CT
Dr. Divya Colin
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.

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