CDSCO Panel Clears BDR Pharma's Abiraterone Oral Suspension, Seeks Phase IV Trial

The firm presented Bioequivalence (BE) fasting and fed study reports comparing Abiraterone Acetate Oral Suspension 1000 mg/5 mL with Abiraterone Tablets 500 mg × 2 before the committee. The submission was made in continuation of the SEC’s earlier recommendation dated May 15, 2024, for the same indication as the already approved tablet formulation.

After detailed deliberation, the committee accepted the BE fasting and fed study results and recommended granting permission to manufacture and market the oral suspension formulation of Abiraterone Acetate for the applied indication, which aligns with that of the tablet dosage form.

However, the recommendation has been made subject to a key condition — the company must conduct a Phase IV Clinical Trial in 400–500 subjects to assess post-marketing safety and clinical outcomes. The SEC has directed the firm to submit the Phase IV Clinical Trial protocol within three months from the date of product approval to CDSCO for further review and clearance.

Abiraterone Acetate is a potent androgen biosynthesis inhibitor that blocks CYP17A1 enzyme activity, thereby reducing androgen production, which fuels prostate cancer growth. It is indicated for the treatment of metastatic castration-resistant prostate cancer (mCRPC) and has become a key therapeutic option globally.

BDR Pharmaceuticals International Pvt Ltd, an Indian oncology-focused pharmaceutical company headquartered in Mumbai, is known for its research and manufacturing of affordable cancer treatments. With this approval, BDR aims to expand patient access to a more convenient oral suspension formulation that may improve compliance among prostate cancer patients.

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