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Home » FDA Moves to Reject Ista Eye Drug’s Larger Bottle Size On Safety Concern
FDA Moves to Reject Ista Eye Drug’s Larger Bottle Size On Safety Concern
August 5, 2011
The FDA is moving to reject Ista Pharmaceuticals’ sNDA for a larger bottle size for its Bromday ophthalmic solution, because using the same bottle to treat both eyes “may pose a potential risk of microbial infection.”