FDA approves additional strengths of SOLODYN for inflammatory lesions treatment

Aug 30 2010

Medicis (NYSE:MRX) today announced that the U.S. Food and Drug Administration (FDA) has approved additional strengths of SOLODYN^® (minocycline HCl, USP) Extended Release Tablets in 55 mg, 80 mg and 105 mg dosages for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. The Company believes all forms of SOLODYN currently approved for use, including the 55 mg, 80 mg and 105 mg dosages, are covered by its patent rights, which include several issued patents and two patent applications for which the U.S. Patent and Trademark Office (USPTO) recently issued Notices of Allowance.

"We are very pleased to announce the approval of these additional strengths of SOLODYN, the most prescribed branded dermatology product in the United States and leading dermatology product by dollars worldwide," said Jonah Shacknai, Chairman and Chief Executive Officer of Medicis. "These three new strengths will complement the current SOLODYN lineup to offer physicians greater weight-based dosing precision of SOLODYN, and make SOLODYN the first and only extended release minocycline with eight FDA-approved dosing strengths. We believe physicians and patients will appreciate the value of this greater dosing precision."

According to the American Academy of Dermatology, acne is the most common skin disorder in the U.S., affecting 40 million to 50 million Americans. In 2009, there were over 4 million patient visits to dermatologists for acne.Greater than 5.6 million prescriptions were written by dermatologists for minocycline, doxycycline and/or tetracycline, totaling over $1.2 billion in branded and generic retail dollars. Approximately 35% of the 5.6 million prescriptions were written for branded products.