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. 2015 Jul 29;93(10):674–683. doi: 10.2471/BLT.14.151290

Table 2. Products approved by the United States Food and Drug Administration in 2011 and 2012 that were tested in pivotal trials in Latin America.

Non-proprietary name Commercial name Pharmaceutical company Countries where pivotal clinical trials were conducted
Aclidium bromide Tudorza Pressair®/Eklaire Genuari® Forest/Almirall Peru
Aflibercept Eylea®/Eylia® Bayer Argentina, Brazil, Chile, Colombia, Mexico
Apixaban Eliquis®/Elicuis® BMS Argentina, Brazil, Chile, Colombia, Mexico, Peru
Axitinib Inlyta® Pfizer Brazil
Azilsartan, medoxomil Edarbi® Takeda Argentina, Chile, Mexico, Peru
Bedaquiline Sirturo® Janssen Brazil
Belatacept Nulojix® BMS Argentina, Brazil, Chile, Mexico,
Belimumab Benlysta® GSK Argentina, Brazil, Chile, Colombia, Costa Rica, Mexico, Peru
Bosutinib Bosulif® Pfizer Argentina, Brazil, Chile, Colombia, Mexico, Peru
Cabozantinib Cometriq® Exelixis/Sobi Brazil, Chile, Peru
Crizotinib Xalkori® Pfizer Brazil
Elvitegravir/obicistat/ emtricitabine/tenofovir disoproxil fumarate Stribild® Gilead Mexico
Enzalutamide Xtandi® Raffo/Astellas Argentina, Chile
Ezogabine Potiga® GSK Argentina, Brazil, Mexico
Indacaterol maleate Arcapta Neohaler®/Onbrize® Novartis Argentina, Chile, Colombia, Ecuador, Peru
Ipilimumab Yerboy®/Yervoy® BMS Argentina, Brazil, Chile, Peru
Linagliptin Tradjenta® Boehringer Argentina, Mexico
Lucinactant Surfaxin® Discovery Brazil, Chile, Ecuador, Mexico, Panama, Uruguay
Pasireotide Signifor® Novartis Argentina, Brazil, Mexico
Perampanel Fycompa® Eisai Argentina, Chile, Mexico
Pertuzumab Perjeta® Genentech/Roche Brazil, Mexico, Peru
Regorafenib Stivarga® Bayer Argentina, Brazil
Rilpivirine Edurant® Janssen Argentina, Brazil, Chile, Costa Rica, Mexico, Panama
Rivaroxavan Xarelto® Bayer/Janssen Argentina, Brazil, Chile, Colombia, Mexico, Peru, Venezuela (Bolivarian Republic of)
Roflumilast Daliresp®/Daxas® Forest/Takeda Brazil
Taliglucerase alfa Elelyso®/Uplyso® Pfizer Chile
Tbo-filgastrim Neutroval®/Granix® Teva Brazil, Chile
Telaprevir Incivek® Janssen/Vertex Argentina, Brazil
Teriflunomide Aubagio® Genzyme Chile, Colombia
Ticagrelor Brilinta® AstraZeneca Argentina, Brazil, Mexico,
Tofacitinib Xeljan® Pfizer Argentina, Brazil, Chile, Colombia, Costa Rica, Dominican Republic, Mexico, Peru, Venezuela (Bolivarian Republic of)
Vandetanib Caprelsa® AstraZeneca Argentina, Brazil, Mexico
Ziv-aflibercept Zaltrap® Sanofi Argentina, Brazil, Chile, Colombia, Mexico