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