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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CDER's Rejection Of Larger Bromday Bottle Rests On Hypothetical Risk, ISTA Says
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.
Safety Concerns Over Larger Bottle For ISTA's Bromday Could Impact Other Eye Drugs
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.
At Tofersen Panel Review, US FDA Shined A Light On Internal Differences Of Opinion
Agency’s presentations on Biogen/Ionis’ ALS drug included differing viewpoints from the statistical and clinical pharmacology teams; the transparency and emphasis on a multidisciplinary review approach may reflect lessons learned from missteps at the Aduhelm panel review in 2020.