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BDR Pharmaceuticals gets CDSCO panel nod to manufacture, market anticancer drug Abiraterone Acetate Oral Suspension
![BDR Pharmaceuticals gets CDSCO panel nod to manufacture, market anticancer drug Abiraterone Acetate Oral Suspension BDR Pharmaceuticals gets CDSCO panel nod to manufacture, market anticancer drug Abiraterone Acetate Oral Suspension](https://medicaldialogues.in/h-upload/2024/06/04/750x450_240158-bdr-pharmaceuticals-new-50.webp)
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.
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.
Also Read:Boehringer Ingelheim Spevigo injection for generalized pustular psoriasis flares gets CDSCO nod
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-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: editorial@medicaldialogues.in. Contact no. 011-43720751