New Delhi: The drug major Sun Pharma has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the bioequivalence study of anticancer drug Leuprolide acetate depot suspension 7.5mg/vial (1 Month Depot), a man-made form of gonadotropin-releasing hormone (GnRH) that is used in men to treat the symptoms of prostate cancer.
This came after the drug major Sun Pharma presented bioequivalence study protocol No. C1B03530, Version No. 01dated 18-Sep-2023.
Bioequivalence of a drug product is achieved if its extent and rate of absorption are not statistically significantly different from those of the reference product when administered at the same molar dose.
Leuprolide acetate is a synthetic nonapeptide that is a potent gonadotropin-releasing hormone receptor (GnRHR) agonist used for diverse clinical applications, including the treatment of prostate cancer, endometriosis, uterine fibroids, central precocious puberty, and in vitro fertilization techniques.
Leuprolide is a medication used in the management and treatment of prostate cancer, endometriosis, uterine fibroids, precocious puberty, and other sex hormone-related conditions.
Leuprolide is indicated for the treatment of advanced prostate cancer and as a palliative treatment of advanced prostate cancer. It is also used for the treatment of pediatric patients with central precocious puberty (CPP).
In combination with oral norethisterone (also known as norethindrone), leuprolide is also indicated for the initial treatment of the symptoms of endometriosis. Finally, in combination with iron supplementation, leuprolide is indicated for the preoperative hematological improvement of anemic patients with uterine leiomyomata (uterine fibroids).
At the recent SEC meeting for oncology held on the 9th and 10th of January 2023, the expert panel reviewed the bioequivalence study protocol presented by the drug major Sun Pharma.
After detailed deliberation, the committee recommended approval of the conduct of the bioequivalence (BE) study as presented by the firm
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