Dr. Reddy proposal to market antidiabetic FDC of Imeglimin and Vildagliptin rejected by CDSCO Panel
New Delhi: Noting that the clinical experience with the drug Imeglimin is very limited, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has rejected pharma major Dr. Reddy's proposal to manufacture and market the anti-diabetic fixed dose combination (FDC) drug Imeglimin HCI plus Vildagliptin Tablets, 1000mg/50mg.
This came in line with the proposal presented by drug maker Dr. Reddy's for the grant of permission to manufacture and market FDC of imeglimin HCL and vildagliptin tablets, 1000mg/50mg alongwith bioequivalence (BE) and a Phase III clinical trial, before the committee.
Vildagliptin (LAF237) is an orally active antihyperglycemic agent that selectively inhibits the dipeptidyl peptidase-4 (DPP-4) enzyme. It is used to manage type II diabetes mellitus, where GLP-1 secretion and insulinotropic effects are impaired.
Glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP) are incretin hormones that regulate blood glucose levels and maintain glucose homeostasis. It is estimated that the activities of GLP-1 and GIP contribute more than 70% to the insulin response to an oral glucose challenge. They stimulate insulin secretion in a glucose-dependent manner via G-protein-coupled GIP and GLP-1 receptor signalling.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.