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.
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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.