New Delhi: The Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organisation (CDSCO), has opined Astellas Pharma India to update the prescribing information of Enzalutamide 40 mg soft capsule after reviewing the results of a Phase IV clinical study.

This came after Astellas Pharma India presented Phase IV clinical trial report of Enzalutamide 40 mg soft Capsule along with the Serious Adverse Event (SAEs) reported, before the committee.

Firm presented study objective, study design, study endpoints, Inclusion and Exclusion criteria, safety assessment, demographic & baseline characteristics, study population, efficacy results, safety results TEAEs reported during study, Drug related Serious Treatment-Emergent Adverse Events (TEAEs) etc.

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