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Safety Concerns Over Larger Bottle For ISTA's Bromday Could Impact Other Eye Drugs

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA's Center for Drug Evaluation and Research refused to approve ISTA's sNDA for a larger fill size of the topical non-steroidal anti-inflammatory because it does not believe a single bottle should be used to dose drug in both eyes.

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Bromday Larger Bottle Gets Wink From Advisory Cmte. Still Torn On Safety

FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee said there are good reasons for FDA to approve larger fill sizes for Ista’s ocular anti-inflammatory drops, although there isn’t enough evidence to say using them in both eyes would be safe.

Rx Safety Conundrum: Where Does Labeling Stop And Medical Practice Begin?

FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee agreed with ISTA Pharmaceuticals that there wasn’t enough safety data to make a decision about the risks associated with using a single bottle of anti-inflammatory eyedrops for both eyes, but decided to come down on the side of caution.

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.

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