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FDA legal threat over eye medication advertising

US pharmaceutical company Imprimis has been accused of making false or misleading claims that its compounded eye medicines were FDA-approved.

The allegations were made in a letter posted to the FDA’s website that focused on the company’s Dropless Therapy, LessDrops, Simple Drops, and Klarity C-Drops products, which are used in connection with eye surgery.

According to the letter the products were made by Imprimis compounding pharmacies that do not make FDA-approved drugs.

It further accused the company of violating the Federal Food, Drug and Cosmetic Act by falsely advertising on its website that Simple Drops and Klarity C-Drops were made with FDA approved components, while omitting important risk information including side effects.

The FDA has advised Imprimis that it should remedy the situation quickly or risk legal action.

The letter was released at the same time as Imprimis is contesting a lawsuit by Allergan, which has also accused the company of illegally selling and advertising unapproved drugs.

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