Synokem Pharma Gets CDSCO Panel Nod To Manufacture, Market Antidiabetic FDC
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New Delhi: Granting the Phase III clinical trial study waiver for the proposed antidiabetic fixed-dose combination (FDC), the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has given its nod to pharma major Synokem Pharma for manufacturing and marketing the fixed-dose combination drug, Teneligliptin plus Metformin plus Dapagliflozin Film-coated bilayered tablet.
This came after the firm presented its justification for a Phase III clinical trial study waiver for the proposed FDC based on Phase III clinical trial study conducted on FDC of Dapagliflozin plus Teneligliptin (5mg+20mg & 10mg+20mg) tablets.
Teneligliptin is a dipeptidyl peptidase 4 (DPP-4) inhibitor. Teneligliptin inhibits the action of DPP-4 enzymes and slows down the rapid degradation of incretins. It also increases insulin synthesis by the pancreas and decreases glucagon levels which are a counter-hormone of insulin, thereby further decreasing blood sugar levels.
The Committee noted that the firm has conducted a Phase III CT study for the FDC of Dapagliflozin plus Teneligliptin (5mg+20mg & 10mg+20mg) tablets along with background therapy with Metformin.
After detailed deliberation, the committee considered the request of the firm for Phase III CT waiver and recommended for grant of permission to manufacture and market the product with the condition that a Phase IV clinical trial should be conducted.
Accordingly, the expert panel directed that the Phase IV clinical trial protocol should be submitted to CDSCO within 03 months from the date of approval for review by the SEC.
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