New Delhi: The Subject Expert Committee (SEC), functioning under the Central Drugs Standard Control Organisation (CDSCO), has opined that Biocon Pharma furnish additional data regarding the subacute toxicity and serious adverse event (SAE) reports related to its proposed Semaglutide Solution for Injection in prefilled pens (2 mg/1.5 mL, 4 mg/3 mL, and 8 mg/3 mL, 6.8 mg/3 mL, 9.6 mg/3 mL; synthetic origin).

This came after Biocon Pharma presented the data/information on survived and dead animals along with a causality assessment of animals that died during the subacute toxicity study and data/information on serious adverse events (SAE) reported in the BE study.

The expert panel directed the firm to present the daily monitoring data for physiological parameters, particularly animals with

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