Inadequate Labeling on Ophthalmic Drugs Draws Warnings for Akorn, Bausch + Lomb
Akorn and Bausch + Lomb have received warning letters from the FDA for marketing unapproved ophthalmic drugs containing pilocarpine hydrochloride at various strengths.
Because the products require a prescription, their current labeling lacks adequate instructions for use, the agency said in separate warning letters posted to its website Tuesday.
In both cases, the FDA said it would not take action against the companies as long as they agree to stop manufacturing the products within 90 days and halt interstate shipments within 180 days.
Labeling is an intense and detail-oriented process that can cause major problems with the slightest slipup. But worry not. Next week, an elite group of drug and biologic industry executives, FDA officials, industry attorneys and thought leaders convene at the Third Annual Pharmaceutical Labeling Summit to discuss and debate the future and implications of the ongoing tug-of-war that is pharmaceutical labeling and revision.
Let their expertise help you get the FDA’s OK on your next labeling change! Mark your calendar for the Summit, taking place this Tuesday and Wednesday, in Washington, D.C.
Come for this valuable opportunity to hear FDA officials discuss regulatory plans and objectives — and ask questions you need answered; learn from device industry experts, consultants and other experts with actionable tips and strategies you can take straight back to the office; and network with other professionals who understand your challenges; share war stories and insights over a drink. Register Today.Read More
The FDA's new enforcement plan makes one thing clear: Developing a successful CAPA program has never been more important. But creating an FDA-proof CAPA isn’t easy. If only you could pick the brain of someone who is coping successfully with CAPA — the best and the brightest, an industry leader who has devised programs, procedures and solutions that have put companies out in front with the FDA. Well, you can. Register today.Read More
The FDA’s cadre of freshly trained inspectors — many of whom come directly from industry — and increased focus on specialized inspections are making it harder than ever to predict the outcome of your next FDA inspection. Unless, of course, you have Surviving an FDA Inspection at your fingertips. If you could spend less than $400 to get your drug manufacturing facility fully prepared to face a tough inspection by the FDA, would you even hesitate? ... Of course not!