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 2024-06-08 16:37 GMT | Update On 2024-06-08 16:37 GMT
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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.
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