Bromday Battle Broadens: Ocular Drug Infection Risks, Fill Size Limits Will Get FDA Cmte. Scrutiny
The Dermatologic and Ophthalmic Drugs Advisory Committee will meet Feb. 27 to discuss issues at the heart of Bromday marketer ISTA Pharmaceuticals’ dispute with the Center for Drug Evaluation and Research over post-operative use of a single-bottle ophthalmic agent in both eyes.
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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.
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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