Bausch & Lomb, Akorn Warned Over Unapproved Eye Drugs

Law360, New York (October 10, 2012, 7:08 PM EDT) -- The U.S. Food and Drug Administration on Tuesday revealed warning letters it sent to eye care companies Bausch & Lomb Inc. and Akorn Inc. last week, claiming they marketed ophthalmic drugs used to treat glaucoma that have not been approved by the agency.

The FDA said Bausch & Lomb manufactured six ophthalmic solutions containing the anti-glaucoma drug pilocarpine hydrochloride, while Akorn manufactured three solutions containing the drug without FDA approval, a violation of the Federal Food, Drug and Cosmetic Act.

Glaucoma is a disease in which...
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