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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.