CDSCO panel tells Glenmark to submit complete clinical trial report on antidiabetic FDC Drug
In response to drug major Glenmark proposal to manufacture and market the antidiabetic fixed dose combination Lobeglitazone Sulphate 0.5/0.5mg plus Metformin HCL 500/1000mg ER tablets, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has recommended Glenmark to submit the complete clinical trial report.
This came after the drug maker Glenmark presented their proposal for manufacturing and marketing of Lobeglitazone Sulphate 0.5/0.5mg plus Metformin HCL 500/1000mg ER tablets along with safety efficacy and safety data.
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Dr. Nandita Mohan
BDS, MDS( Pedodontics and Preventive Dentistry)