CDSCO panel rejects USV Pharmaceuticals' proposal of CT study waiver for fenofibrate tablets in diabetic retinopathy
New Delhi: Noting that the presented safety data was not adequate in terms of long-term safety, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has rejected the clinical trial study waiver proposal presented by USV Pharmaceutical for manufacturing and marketing Fenofibrate 160 mg tablets (additional indication) indicated for the reduction in the progression of diabetic retinopathy in patients with Type 2 diabetes and existing diabetic retinopathy.
This came after the firm presented their proposal for a grant of permission to manufacture and market fenofibrate 160 mg tablets (additional indication) indicated for the reduction in the progression of diabetic retinopathy in patients with type 2 diabetes and existing diabetic retinopathy along with justification for a waiver of the clinical trial study.
The firm did not present the bioequivalence (BE) study protocol during deliberation, which was submitted to CDSCO.
The committee noted that the presented safety data was not adequate in terms of the long-term safety of the applied product in the proposed indication.
Fenofibrate, a cholesterol-lowering medication, has shown promise in slowing the progression of diabetic retinopathy in some studies, particularly in those with early or pre-proliferative retinopathy. Diabetic retinopathy, a common and sight-threatening microvascular complication of diabetes mellitus, is a leading cause of blindness among working-aged adults.
At the recent SEC meeting for ophthalmology held on 19th March 2025, the expert panel reviewed the proposal for grant of permission to manufacture and market Fenofibrate 160 mg tablets (additional indication) indicated for the reduction in the progression of diabetic retinopathy in patients with Type 2 diabetes and existing diabetic retinopathy along with justification for waiver of clinical trial study.
After detailed deliberation, the committee did not recommend a clinical trial study waiver.
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