Alkem Gets CDSCO Panel Nod To Manufacture, Market Linagliptin, Dapagliflozin antidiabetic FDC
New Delhi: The drug major Alkem Health Sciences has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to manufacture and market the antidiabetic fixed-dose combination (FDC) drug Linagliptin 5mg/5mg plus Dapagliflozin 10mg/5mg tablets.
This came after the drug major Alkem Health Sciences presented the Phase III clinical trial report of the antidiabetic fixed-dose combination (FDC) drug Linagliptin plus Dapagliflozin in one strength i.e 5mg + 10mg tablet before the committee.
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).
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.
Dapagliflozin is mainly used to treat type 2 diabetes. It can also be used to treat heart failure and chronic kidney disease (CKD).
At the recent SEC meeting for Endocrinology and Metabolism held on 18th and 19th May 2023, the expert panel reviewed the Phase III clinical trial report of the FDC antidiabetic drug Linagliptin5mg/5mg plus Dapagliflozin 10mg/5mg tablets.
After detailed deliberation, the committee recommended the grant of permission to manufacture and market the product in the said strength
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