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Specter of Bromday Dispute Will Haunt Advisory Panel Discussion of Ophthalmic Product Labeling Changes

 
• By Martin Berman-Gorvine

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.

FDA is asking its Dermatologic and Ophthalmic Drugs Advisory Committee whether labeling changes could address the risks of cross-infection posed by patients using a single bottle of an anti-inflammatory ophthalmic product to treat both eyes after surgery, but the issue of Ista Pharmaceuticals Inc.’s rejected sNDA for a larger fill size of its ocular agent Bromday (bromfenac ophthalmic solution 0.09%) implicitly looms large over the Feb. 27 meeting.

At the very beginning of a background document posted in advance of the meeting, FDA notes that “CDER...

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