Submit safety and efficacy data: CDSCO panel Tells Zydus on Anticancer Drug Relugolix
New Delhi: In response to the drug major Zydus's proposal for the manufacture and marketing of the drug Relugolix 120 mg tablets, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to present the safety and efficacy data of the anticancer drug Relugolix (innovator).
This came after the drug major Zydus presented its proposal for the manufacture and marketing of the drug Relugolix 120 mg tablets indicated for the treatment of adult patients with advanced prostate cancer along with bioequivalence (BE) study report and justification for the local clinical trial waiver.
Innovator Drug refers to a drug that receives a patent on its chemical formulation or manufacturing process, obtains approval from the FDA or any regulatory authority after extensive testing, and is sold under a brand name.
Relugolix is a gonadotropin-releasing hormone (GnRH) receptor antagonist used in the treatment of several hormone-responsive conditions. It was first approved in Japan in 2019, under the brand name Relumina, for the symptomatic treatment of uterine fibroids, and more recently by the United States FDA in 2020, under the brand name Orgovyx, for the treatment of advanced prostate cancer. This branded product was later approved by the European Commission on April 29, 2022. Relugolix has also been studied in the symptomatic treatment of endometriosis.
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