Last Updated on December 10, 2021 by The Health Master
New Delhi: Approving the waiver of the phase 3 clinical trial, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has granted pharma major Sun Pharma the right to manufacture and market the Brinzolamide IP 10mg plus Timolol Maleate IP 5mg plus Potassium Sorbate IP 0.47% w/v ophthalmic suspension.
This came after drug-maker Sun Pharma presented their proposal for manufacturing and marketing Brinzolamide IP 10mg plus Timolol Maleate IP 5mg plus Potassium Sorbate IP 0.47% w/v ophthalmic suspension along with a request for a waiver to conduct a Phase III clinical trial.
At an earlier SEC meeting on August 27, 2021, the committee noted that no ophthalmic formulation is approved with potassium sorbate in the country and potassium sorbate may alter the ocular bioavailability of Timolol.
The committee noted that the FDC is already approved and the firm is changing the preservative from BKC to potassium sorbate. The committee also noted that the frequency of administration as well as dose remain the same as that of the already approved FDC.
After detailed deliberation, the committee recommended the grant of permission for manufacturing and marketing of the proposed FDC with the condition that the firm conduct a Phase IV clinical trial.
Further, the committee directed that a phase IV clinical trial protocol should be submitted within 3 months of the product’s approval.
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