The FDA has approved Medicis's NDA for Solodyn (minocycline HCl, USP) extended release tablets. Solodyn is the only oral minocycline approved for once daily dosage in the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Solodyn is also the only approved minocycline in extended release tablet form. Solodyn is lipid soluble, and its mode of action occurs in the skin and sebum. Solodyn is not bioequivalent to any other minocycline products, and is in no way interchangeable with other forms of minocycline.

The dosing and administration for Solodyn is unique, and redefines minocycline therapy for acne. Based on extensive multi-year clinical trials conducted by Medicis in which over 1,000 patients participated, the recommended dosage for Solodyn is 1 mg/kg daily

According to the release, Solodyn is patented until 2018 by U.S. Patent No. 5,908,838, which covers Solodyn's unique dissolution rate. Other patents covering solodyn's dosing, pharmacokinetics, and carrier composition are pending. The company continues to seek additional patent protection for its products.

Jonah Shacknai, chairman and CEO of Medicis commented, "Having the only oral patented minocycline extended release tablet for acne with once daily dosage is indicative of the innovation of our product pipeline. We believe Solodyn's unique, weight-based dosing will transform the way doctors prescribe minocycline, and improve the overall safety of oral antibiotic use in acne. With this highly specialized dosing method and safety profile, we believe Solodyn will be a leader in the oral antibiotic market for acne, where US dermatologists prescribe minocycline more frequently than any other molecule."