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news.Canadian pharmaceutical firm Theratechnologies has received approval from Mexico's health agency, Cofepris, for 2mg/vial presentation of Egrifta (tesamorelin for injection) for the treatment of lipodystrophy.
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The company’s partner, Sanofi, will re-submit a file to the Mexican health agency to seek approval of the 1mg/vial presentation of Egrifta which is currently marketed in other territories.
The commercialization of Egrifta in Mexico will be started after securing approval of the 1mg/vial presentation.
Theratechnologies president and CEO Luc Tanguay said: "We are very pleased with Cofepris’ 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."
Initially, Egrifta was approved by the US Food and Drug Administration in November 2010 and was recently approved by Health Canada in March this year.
Theratechnologies is focused on addressing unmet medical needs in metabolic disorders to promote healthy ageing and an improved quality of life.