FDANews

AUXILIUM GETS CANADIAN APPROVAL TO MARKET TESTIN

Auxilium Pharmaceuticals, headquartered in Malvern, Pa., has reported that Health Canada's Therapeutic Products Directorate has granted marketing approval for Testim, the company's topical testosterone gel for the treatment of hypogonadism (low testosterone). Testim is currently approved for sale in 15 countries outside the U.S.

"The approval complements Testim's regulatory approvals in the U.S. and in Europe," said Gerri Henwood, CEO of Auxilium. "We are pleased to expand Testim's global reach to include Canada, the fourth fastest growing pharmaceutical market in the world."

Hypogonadism affects approximately 20 percent of the U.S. male population over age 50. The conditon involves a reduced or absent secretion of testosterone, which can lead to loss of libido, adverse changes in body composition, irritability and poor concentration.