Mr. Luc Tanguay reports
EGRIFTA (TESAMORELIN FOR INJECTION) APPROVED IN MEXICO
COFEPRIS, Mexico's health agency, has approved the two-milligram/vial presentation of Theratechnologies Inc.'s tesamorelin for the treatment of lipodystrophy.
Theratechnologies' partner, sanofi, will resubmit a file to COFEPRIS to seek approval of the one mg/vial presentation of Egrifta, which is the one currently marketed in other territories. As was the case with Canada, the commercialization of Egrifta in Mexico will be initiated upon obtaining approval of the one mg/vial presentation.
"We are very pleased with COFEPRIS's decision. We view Mexico as the cornerstone of Latin America for Egrifta and we are proud that Egrifta may soon be available to the Latin American population," said Luc Tanguay, president and chief executive officer, Theratechnologies.
Egrifta was first approved by the United States Food and Drug Administration in November, 2010, and was recently approved in March, 2015, by Health Canada.
We seek Safe Harbor.
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