BDR Pharmaceuticals gets CDSCO panel nod to manufacture, market anticancer drug Abiraterone Acetate Oral Suspension

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-06-08T22:07:04+05:30 | Updated On 8 Jun 2024 10:07 PM IST

New Delhi: In a significant development, BDR Pharmaceuticals has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market the anticancer drug Abiraterone Acetate Oral Suspension 1000 mg/5 ml.

The nod came along with a phase III clinical trial waiver with the condition to conduct a phase IV clinical trial in 400–500 subjects.

This took place after BDR Pharmaceuticals presented its justification for the waiver of the Phase III clinical trial before the committee.

The firm has informed that the proposed drug formulation, Abiraterone Acetate Oral Suspension 1000 mg/5ml, has no change in route of administration and no change in dosing regimen.

"Abiraterone Acetate 1000 mg tablets approved in the EU by 2021," the firm added.

Abiraterone is an antiandrogen used in the treatment of metastatic castration-resistant prostate cancer and metastatic high-risk castration-sensitive prostate cancer.

Abiraterone is a potent, irreversible, and selective inhibitor of 17 αhydroxylase/C17,20-lyase (CYP17), an enzyme expressed in testicular, adrenal, and prostatic tumor tissues, to regulate androgen biosynthesis.

At the recent SEC meeting for oncology held on May 15, 2024, the expert panel reviewed the justification for waiver of the Phase III clinical trial of the anticancer drug Abiraterone Acetate.

After detailed deliberation, the committee has opined for the grant of manufacturing and marketing of Abiraterone Acetate Oral Suspension 1000 mg/5 ml along with a Phase III clinical trial waiver with the condition of conducting a Phase IV clinical trial in 400–500 subjects.

Accordingly, the expert panel suggested that the firm submit the Phase IV Clinical Trial protocol within 3 months from the date of approval of the product to CDSCO for further review by the committee.

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Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751