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

 
• By Martin Berman-Gorvine

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.

FDA should approve a larger fill size for Ista Pharmaceuticals Inc.’s Bromday (bromfenac ophthalmic solution 0.09%) postoperative eye drops for reasons of patient and physician convenience, an FDA advisory committee said, although the lack of safety data on use of the same bottle for both eyes left the panel opposed to labeling the larger size for binocular use.

Ophthalmic Advisory

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