CDSCO Panel Clears MSN Labs' Abiraterone Acetate 1000 mg, Mandates Phase IV Trial
New Delhi: The Subject Expert Committee (SEC) on Oncology, under the Central Drugs Standard Control Organisation (CDSCO), has recommended the grant of permission to MSN Laboratories Private Limited for the manufacture and marketing of Abiraterone Acetate Tablets 1000 mg, after reviewing the firm's bioequivalence (BE) report and clinical trial waiver justification.
According to the recommendations made at the SEC (Oncology) meeting held on September 23, 2025, the proposal was presented by the firm in light of an earlier SEC recommendation dated July 9, 2024. The company sought approval to manufacture and market Abiraterone Acetate Tablets 1000 mg along with a BE report under fasting conditions, submitting supporting justification for a waiver of clinical trial (CT) study before the committee.
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