Sanofi gets CDSCO panel nod to market Biphasic Insulin Aspart Injection
New Delhi: With a condition of conducting a phase IV study, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has granted approval to drug major Sanofi to import and market biphasic Insulin Aspart Injection IP 100 Units/mL, used to improve blood sugar control in adults and children with diabetes mellitus.
This approval is subject to the condition that the firm conduct a Phase IV study and that the protocol submission be done within three months of importing and marketing approval.
This came after the firm presented a proposal for the grant of permission to import and market the biphasic insulin aspart injection IP 100 units/mL with the results of a global clinical trial, including study data on Indian patients.
Insulin aspart is a short-acting, manmade version of human insulin. It works by replacing the insulin that is normally produced by the body and by helping move sugar from the blood into other body tissues where it is used for energy. It also stops the liver from producing more sugar.
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