Rx Safety Conundrum: Where Does Labeling Stop And Medical Practice Begin?
This article was originally published in The Pink Sheet Daily
FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee agreed with ISTA Pharmaceuticals that there wasn’t enough safety data to make a decision about the risks associated with using a single bottle of anti-inflammatory eyedrops for both eyes, but decided to come down on the side of caution.
You may also be interested in...
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.
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.
Gathering more data to assuage concerns about possibly lower efficacy in black patients will be key to converting the accelerated approval to full approval for the tuberculosis drug, FDA’s Anti-Infective Drugs Advisory Committee concludes.