Bausch & Lomb Warned for Marketing Unapproved Drugs
Bausch & Lomb Inc. and Akorn Inc. were sent warning letters for manufacturing and marketing ophthalmic drugs to treat glaucoma that have not been approved by the Food and Drug Administration (FDA).
Law360 (subscription required) reports that Bausch & Lomb and Akorn violated the Federal Food, Drug and Cosmetic Act (FFDCA) when they manufactured eye solutions containing the anti-glaucoma drug pilocarpine hydrochloride without the approval of the federal watchdog. The solutions containing the drug also lacked the required directions for intended uses on their label.
Glaucoma is an eye disease in which fluid builds up and puts pressure on the optic nerve. If left untreated it can result in loss of vision. Pilocarpine hydrochloride helps to drain out excess eye fluid, thereby decreasing eye pressure.
The companies will face strict federal action if manufacturing is not stopped completely within 90 days or shipping is not stopped within 180 days of the warning, according to Law360 .
Bausch & Lomb told Law360 the company ceased production of the products mentioned in the FDA warning letter and hasn’t made them for a quite a while.