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District Court Issues Permanent Injunction to Seller of Unapproved Dermatological Drugs

August 2, 2017

The U.S. District Court for the Eastern District of Tennessee entered a permanent injunction against Crown Laboratories of Johnson City and its CEO, Jeffrey Bedard, for distribution of unapproved and misbranded drugs.

The company’s products, which include urea creams and lotions intended to treat dermatological problems, were sold and distributed without FDA approval or a sufficient demonstration of their safety and efficacy, according to the complaint the Justice Department filed in March at the request of the FDA.

Several of Crown’s products were sold with an indication for treatment of dry, rough skin, skin cracks and fissures, dermatitis, xerosis, icthyosis, eczema, calluses, and psoriasis. One of its products, Sodium Sulfacetamide, was indicated for acne vulgaris, seborrheic dermatitis and acne rosacea. All of these uses required FDA approval, which was not secured.

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