Micro Labs Gets CDSCO Panel Nod To Manufacture, Market Antidiabetic FDC Drug

This came after the firm presented a Phase III clinical trial report of the FDC antidiabetic drug Linagliptin 5mg/2.5mg/2.5 mg plus Dapagliflozin 10mg/10 mg/5 mg tablets.

Linagliptin is in a class of medications called dipeptidyl peptidase-4 (DPP-4) inhibitors. It works by increasing the amounts of certain natural substances that lower blood sugar when it is high.

Linagliptin is a medicine used to treat type 2 diabetes. Type 2 diabetes is a condition where the body does not make enough insulin, or the insulin that it makes does not work properly. This can cause high blood sugar levels (hyperglycemia).

Linagliptin is an inhibitor of DPP-4, an enzyme that degrades the incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP).

Dapagliflozin is mainly used to treat type 2 diabetes. It can also be used to treat heart failure and chronic kidney disease (CKD). Dapagliflozin is usually prescribed if: you have type 2 diabetes and cannot take metformin.

Dapagliflozin is in a class of medications called sodium-glucose co-transporter 2 (SGLT2) inhibitors. It lowers blood sugar by causing the kidneys to get rid of more glucose in the urine.

By inhibiting SGLT2, dapagliflozin blocks the reabsorption of filtered glucose in the kidney, increasing urinary glucose excretion and reducing blood glucose levels. Its mechanism of action is independent of pancreatic β cell function and modulation of insulin sensitivity.

At the recent SEC meeting for Endocrinology and Metabolism held on the 18th May 2023, the expert panel reviewed the Phase III clinical trial of the Linagliptin 5mg/2.5mg/2.5 mg plus Dapagliflozin 10mg/10mg/5mg tablets

After detailed deliberation, the committee recommended the grant of permission to manufacture and market the product in said strength.

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