Eris Lifesciences Gets CDSCO Panel Nod To Manufacture, Market PCOS drug combination
New Delhi: Eris Lifescience has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market the fixed-dose combination drug Myo-Inositol USP- NF plus Metformin Hydrochloride which is used in the treatment insulin resistance Polycystic ovary syndrome (PCOS).
This came after the firm presented the bioequivalence (BE) and clinical trial (CT) reports of Myo-Inositol USP- NF plus Metformin Hydrochloride tablet before the committee.
Metformin plus Myo-Inositol is a combination of two medicines used for the treatment of polycystic ovarian syndrome (PCOS). It helps support regular ovulation and menstrual cycles.
Metformin is a biguanide antihyperglycemic used in conjunction with diet and exercise for glycemic control in type 2 diabetes mellitus. It is also used off-label for insulin resistance in polycystic ovary syndrome (PCOS).
Its pharmacologic mechanisms of action are different from other classes of oral antihyperglycemic agents. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Inositol is used for diabetic nerve pain, panic disorder, high cholesterol, insomnia, cancer, depression, schizophrenia, Alzheimer's disease, attention deficit-hyperactivity disorder (ADHD), autism, promoting hair growth, a skin disorder called psoriasis, and treating side effects of medical treatment with lithium.
At the recent SEC meeting for Reproductive and Urology held on 25th May 2023, the expert panel reviewed the BE and CT reports of Myo-Inositol USP- NF plus Metformin Hydrochloride tablet presented by Eris Life Sciences.
After detailed deliberation, the committee recommended the grant of permission to manufacture and market the proposed product.
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