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SkinMedica to Co-Promote ACZONE(R) (dapsone) Gel 5% to Pediatricians in the U.S.
Date:5/11/2009

ditions once a physician and patient find an appropriate product and dosage.

About ACZONE(R) Gel 5%

ACZONE(R) Gel 5% is an aqueous topical gel formulation containing 5% dapsone. Marketed by Allergan, it was developed by QLT Inc.'s wholly owned subsidiary, QLT USA, Inc., for the treatment of acne vulgaris. Combining dapsone in a Solvent Microparticulate(TM) gel enables dapsone to be applied topically. ACZONE(R) Gel 5% was originally approved by the U.S. Food and Drug Administration (FDA) in July 2005 and by Health Canada in June 2006. On March 17, 2008 and June 5, 2008 the FDA and Health Canada, respectively, removed certain restrictive requirements from the ACZONE(R) Gel 5% label. The most common adverse events reported with ACZONE(R) Gel 5% in controlled clinical trials included oiliness/peeling, dryness, and erythema. There were no significant differences in the adverse event rates between ACZONE(R) Gel 5% and vehicle-control-treated patients.

Important Safety Information

Warnings and Precautions

Hemotological effects: Oral dapsone treatment has produced dose-related hemolysis and hemolytic anemia. Individuals with glucose-6-phosphate dehydrogenese (G6PD) deficiency are more prone to hemolysis with the use of certain drugs. There was no evidence of clinically relevant hemolysis or anemia in patients treated with ACZONE(R) Gel 5%, including patients who were G6PD deficient. Some subjects with G6PD deficiency using ACZONE(R) Gel 5% developed laboratory changes suggestive of mild hemolysis.

If signs and symptoms suggestive of hemolytic anemic occur, ACZONE(R) Gel 5% should be discontinued. ACZONE(R) Gel 5% should not be used in patients who are taking oral dapsone or anti-malarial medications because of the potential for hemolytic reactions. Combination of ACZONE(R) Gel 5% with trimethroprim/sulfamethoxazole (TMP/SMX) may increase the likelihood of hemolysi
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SOURCE SkinMedica, Inc.
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