Rx Safety Conundrum: Where Does Labeling Stop And Medical Practice Begin?
This article was originally published in The Pink Sheet Daily
Executive Summary
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...
Bromday Larger Bottle Gets Wink From Advisory Cmte. Still Torn On Safety
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.
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.
Ranbaxy’s Atorvastatin Recall: Will Glass Shards Nick FDA’s Reputation?
Less than a year after signing a consent decree to resolve compliance problems, the company is forced to stop manufacturing its generic version of the best-selling cholesterol drug. For FDA, the issue poses a public relations challenge since it touches on several areas where the agency has recently been criticized – generic drug quality, manufacturing oversight and drug shortages.