Specter of Bromday Dispute Will Haunt Advisory Panel Discussion of Ophthalmic Product Labeling Changes
This article was originally published in The Pink Sheet Daily
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.
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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.
Center for Drug Evaluation and Research tells FDA Commissioner Margaret Hamburg that resource and regulatory policy considerations warrant postponing action on ISTA’s request for a formal evidentiary hearing on its rejected application for a larger fill size.
An unusual regulatory situation involving ISTA Pharmaceuticals’ ophthalmic drug Bromday could put FDA in the position of testing an infrequently used procedure for refusing to approve an application.