Mr. Denis Boucher reports
THERATECHNOLOGIES PROVIDES REGULATORY UPDATE FOR COLOMBIA
Sanofi, Theratechnologies Inc.'s commercial partner in Colombia, received a letter from the specialized division of drugs and biological products of the reviewer commission of INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) stating that it does not recommend the approval of tesamorelin in this country.
In its correspondence with Sanofi, INVIMA justifies its position by stating that additional long-term safety and efficacy studies are needed.
Theratechnologies and its partner will focus on obtaining approvals in Mexico and Brazil, the two most significant markets in the Latin American region, where the regulatory review process is currently under way. Thereafter, Theratechnologies and its partner will determine if the decision in Colombia will be appealed.
We seek Safe Harbor.
© 2015 Canjex Publishing Ltd. All rights reserved.