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).
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