FDA approves Medicis' minocycline HCl, USP Extended Release Tablets for acne

By Lisa Kerner

Erie, Pa., May 8 - Medicis said the Food and Drug Administration has approved its New Drug Application for Solodyn (minocycline HCl, USP) Extended Release Tablets 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.

The lipid-soluble Solodyn is the only approved minocycline in extended release tablet form and is not bioequivalent to any other minocycline products, according to a company news release.

Medicis said based on multi-year clinical trials with more than 1,000 participating patients, the recommended dosage for Solodyn is 1 mg/kg daily. Higher doses of minocycline, tested against Solodyn, did not show additional therapeutic benefits in the treatment of inflammatory lesions of acne.

"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," chairman and chief executive officer Jonah Shacknai said in the news release.

"With this highly specialized dosing method and safety profile, we believe Solodyn will be a leader in the oral antibiotic market for acne, where U.S. dermatologists prescribe minocycline more frequently than any other molecule."

Medicis is a Scottsdale, Ariz., specialty pharmaceutical company focused on the treatment of dermatological and podiatric conditions and aesthetics medicine.

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