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ISTA To Challenge FDA’s Refusal To Approve Bromday sNDA, Testing Little-Used Hearing Process

Executive Summary

An unusual regulatory situation involving ISTA Pharmaceuticals’ ophthalmic drug Bromday could put FDA in the position of testing an infrequently used procedure for refusing to approve an application.

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Ista Pharmaceuticals’ rejected sNDA for a larger fill size of its ocular agent Bromday won’t be on the formal agenda, but the company will be presenting at the meeting, and the subject is bound to be on the minds of FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee.

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