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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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Specter of Bromday Dispute Will Haunt Advisory Panel Discussion of Ophthalmic Product Labeling Changes

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.

CDER's Rejection Of Larger Bromday Bottle Rests On Hypothetical Risk, ISTA Says

FDA drug reviewers’ rejection of a larger fill size for ISTA Pharmaceuticals’ ocular agent Bromday (bromfenac ophthalmic solution 0.09%) was based on a hypothetical risk from a use that is contrary to product labeling, the company says.

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