FDAnews Drug Daily Bulletin

HEALTH CANADA GRANTS MARKETING APPROVAL TO TESTIM

June 5, 2006
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Health Canada's Therapeutic Products Directorate has granted marketing approval to Testim 1 percent, a topical testosterone gel indicated for the treatment of hypogonadism, Auxilium announced.

Hypogonadism, defined as reduced or absent secretion of testosterone, can lead to loss of libido, adverse changes in body composition, irritability and poor concentration. The condition affects approximately 20 percent of the U.S. male population older than 50.

With the Health Canada approval, Testim is now available in 16 countries worldwide. It was approved by the FDA in 2002.