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.
After detailed deliberation, the committee recommended the acceptance of the BE report and advised that the firm be permitted to manufacture and market Abiraterone Acetate Tablets 1000 mg for the applied indication. However, the approval was given with the specific condition that the firm shall conduct a Phase IV clinical trial to evaluate the product in the post-marketing setting.
Accordingly, the SEC directed that MSN Laboratories must submit the Phase IV Clinical Trial protocol within three months from the date of approval of the product to CDSCO for review by the committee.
Abiraterone acetate, originally developed by Janssen (a Johnson & Johnson subsidiary) and marketed under the brand name Zytiga, is an androgen biosynthesis inhibitor (CYP17 inhibitor) indicated for the treatment of metastatic castration-resistant prostate cancer (mCRPC). The 1000 mg dosage allows for a simplified once-daily regimen.
