Appendix 1: List of 156 NME Or BLA Both Approved by the EMA and the FDA Between 2007 And

Appendix 1: List of 156 NME or BLA both approved by the EMA and the FDA between 2007 and June 30th 2015 with a available CAV. A= Accelerated Assessment Procedure (EMA), O=Orphan, P=Priority Review (FDA)

EMA Name / Active substance / Therapeutic class / Innovative (Yes/No) / Date of EMA MAA / EMA status (A,O) / Date of FDA MAA / FDA status (P,O)
ADCETRIS / Brentuximab / Antineoplastic and immunomodulating agents / Yes / 25/10/2012 / O / 19/08/2011 / P, O
ADEMPAS / Riociguat / Cardiovascular system / No / 27/03/2014 / O / 08/10/2013 / P, O
ADENURIC / Fébuxostat / Musculoskeletal system / No / 21/04/2008 / 13/02/2009
AFINITOR / Evérolimus / Antineoplastic and immunomodulating agents / No / 03/08/2009 / 30/03/2009 / P
AMYVID / florbétapir / Various / No / 14/01/2013 / 06/04/2012 / P
ARZERRA / ofatumumab / Antineoplastic and immunomodulating agents / No / 19/04/2010 / O / 26/10/2009 / P, O
AUBAGIO / tériflunomide / Antineoplastic and immunomodulating agents / No / 26/08/2013 / 12/09/2012
AVAMYS / Fluticasone furoate / Respiratory system / No / 11/01/2008 / 10/05/2013
ATRIANCE / nélarabine / Antineoplastic and immunomodulating agents / Yes / 22/08/2007 / O / 28/10/2005 / P, O
BENLYSTA / bélimumab / Antineoplastic and immunomodulating agents / No / 13/07/2011 / 09/03/2011 / P
BETMIGA / mirabégron / Genito-urinary system and sex hormones / No / 20/12/2012 / 28/06/2012
BOSULIF / bosutinib monohydrate / Antineoplastic and immunomodulating agents / No / 27/03/2013 / O / 04/09/2012 / O
BRILIQUE / Ticagrelor / Blood and blood forming organs / No / 03/12/2010 / 20/07/2011
BRINTELLIX / vortioxétine / Nervous system / No / 18/12/2013 / 30/09/2013
CAPRELSA / vandétanib / Antineoplastic and immunomodulating agents / No / 17/02/2012 / 06/04/2011 / P, O
CELSENTRI / Maraviroc / Anti-infectives for systemic use / No / 18/09/2007 / A / 06/08/2007 / P
CERDELGA / eliglustat / Alimentary tract and metabolism / No / 19/01/2015 / O / 19/08/2014 / P, O
CIMZIA / Certolizumab pégol / Antineoplastic and immunomodulating agents / No / 01/10/2009 / 22/04/2008
COMETRIQ / cabozantinib / Antineoplastic and immunomodulating agents / No / 21/03/2014 / O / 29/11/2012 / P, O
COSENTYX / sécukinumab / Antineoplastic and immunomodulating agents / No / 15/01/2015 / 21/01/2015
CYRAMZA / ramucirumab / Antineoplastic and immunomodulating agents / No / 19/12/2014 / O / 21/04/2014 / P, O
DAKLINZA / daclatasvir / Anti-infectives for systemic use / No / 22/08/2014 / A / 24/07/2015 / P
DACOGEN / decitabine / Antineoplastic and immunomodulating agents / No / 20/09/2012 / 02/05/2006 / O
DAXAS / roflumilast / Respiratory system / No / 05/07/2010 / 28/02/2011
DEXDOR /
dexmedetomidine
/ Nervous system / No / 16/09/2011 / 17/12/1999
DIFICLIR / fidaxomicine / Alimentary tract and metabolism / Yes / 05/12/2011 / 27/05/2011 / P
DORIBAX / doripenem / Anti-infectives for systemic use / No / 25/07/2008 / 12/10/2007
ECALTA / anidulafungin / Anti-infectives for systemic use / No / 20/09/2007 / 17/02/2006
EDURANT /
rilpivirine
/ Anti-infectives for systemic use / No / 28/11/2011 / 20/05/2011
EFIENT / prasugrel / Blood and blood forming organs / No / 23/02/2009 / 10/07/2009 / P
EKLIRA / Aclidinium / Respiratory system / No / 20/07/2012 / 23/07/2012
ELAPRASE / idursulfase / Alimentary tract and metabolism / Yes / 08/01/2007 / O / 24/07/2006 / P, O
ELIQUIS /
apixaban
/ Blood and blood forming organs / No / 18/05/2011 / 28/12/2012 / P
ELLAONE / ulipristal / Genito-urinary system and sex hormones / No / 15/05/2009 / 13/08/2010
ENTYVIO / vedolizumab / Antineoplastic and immunomodulating agents / No / 22/05/2014 / 20/05/2014 / P
ERIVEDGE / vismodegib / Antineoplastic and immunomodulating agents / No / 12/07/2013 / 30/01/2012 / P
ESBRIET / pirfenidone / Antineoplastic and immunomodulating agents / No / 28/02/2011 / O / 15/10/2014 / P, O
EYLEA / aflibercept / Sensory organs / No / 22/11/2012 / 18/11/2011 / P
FAMPYRA / fampridine / Nervous system / No / 20/07/2011 / 22/01/2010 / P, O
FIRAZYR /
icatibant
/ Blood and blood forming organs / No / 11/07/2008 / A, O / 25/08/2011 / P, O
FIRMAGON / degarelix / Antineoplastic and immunomodulating agents / No / 17/02/2009 / 24/12/2008
FORXIGA / dapagliflozin / Alimentary tract and metabolism / No / 12/11/2012 / 08/01/2014
FYCOMPA / perampanel / Nervous system / No / 23/07/2012 / 22/10/2012
GAZYVARO /
obinutuzumab
/ Antineoplastic and immunomodulating agents / Yes / 23/07/2014 / O / 01/11/2013 / P, O
GILENYA /
fingolimod
/ Antineoplastic and immunomodulating agents / No / 17/03/2011 / 21/09/2010 / P
GIOTRIF /
afatinib
/ Antineoplastic and immunomodulating agents / No / 25/09/2013 / 12/07/2013 / P, O
GRASTOFIL / filgrastim / Antineoplastic and immunomodulating agents / No / 18/10/2013 / 29/08/2012
HALAVEN / eribulin / Antineoplastic and immunomodulating agents / No / 17/03/2011 / 15/11/2010 / P
HARVONI / sofosbuvir / ledipasvir / Anti-infectives for systemic use / No / 17/11/2014 / A / 10/10/2014 / P
ICLUSIG / ponatinib / Antineoplastic and immunomodulating agents / Yes / 01/07/2013 / A, O / 14/12/2012 / P, O
ILARIS / canakinumab / Antineoplastic and immunomodulating agents / Yes / 23/10/2009 / 17/06/2009 / P, O
IMBRUVICA /
ibrutinib
/ Antineoplastic and immunomodulating agents / Yes / 21/10/2014 / O / 13/11/2013 / P, O
IMNOVID / pomalidomide / Antineoplastic and immunomodulating agents / Yes / 05/08/2013 / O / 08/02/2013 / O
INCIVO / telaprevir / Anti-infectives for systemic use / Yes / 19/09/2011 / A / 23/05/2011 / P
INCRELEX / mecasermin / Systemic hormonal preparations / Yes / 03/08/2007 / O / 30/08/2005 / P, O
INLYTA / axitinib / Antineoplastic and immunomodulating agents / No / 03/09/2012 / 27/01/2012
INOVELON / rufinamide / Nervous system / No / 16/01/2007 / O / 14/11/2008 / O
INTELENCE /
etravirine
/ Anti-infectives for systemic use / No / 28/08/2008 / 18/01/2008 / P
INVEGA / paliperidone / Nervous system / No / 25/06/2007 / 19/12/2006
INVOKANA / canagliflozin / Alimentary tract and metabolism / No / 15/11/2013 / 29/03/2013
IRESSA / gefitinib / Antineoplastic and immunomodulating agents / No / 24/06/2009 / 05/05/2003 / P
ISENTRESS / raltegravir / Anti-infectives for systemic use / Yes / 20/12/2007 / A / 12/10/2007 / P
JAKAVI / ruxolitinib / Antineoplastic and immunomodulating agents / No / 23/08/2012 / 16/11/2011 / P, O
JANUVIA / sitagliptin / Alimentary tract and metabolism / No / 21/03/2007 / 16/10/2006
JARDIANCE /
empagliflozin
/ Alimentary tract and metabolism / No / 22/05/2014 / 01/08/2014
JEVTANA / cabazitaxel / Antineoplastic and immunomodulating agents / No / 17/03/2011 / 17/06/2010 / P
JETREA / ocriplasmin / Sensory organs / No / 13/03/2013 / 17/10/2012 / P
KADCYLA / trastuzumab emtansine / Antineoplastic and immunomodulating agents / Yes / 15/11/2013 / 22/02/2013 / P
KALYDECO /
ivacaftor
/ Respiratory system / Yes / 23/07/2012 / A, O / 31/01/2012 / P, O
KUVAN / sapropterin / Alimentary tract and metabolism / Yes / 02/12/2008 / O / 13/12/2007 / P, O
LATUDA /
lurasidone
/ Nervous system / No / 21/03/2014 / 28/10/2010
LENVIMA / Lenvatinib mesylate / Antineoplastic and immunomodulating agents / No / 28/08/2015 / A, O / 13/02/2015 / P, O
LOJUXTA / lomitapide / Cardiovascular system / No / 31/07/2013 / 21/12/2012 / O
LUCENTIS / ranibizumab / Sensory organs / Yes / 22/01/2007 / 30/06/2006 / P
LYNPARZA / olaparib / Antineoplastic and immunomodulating agents / No / 16/12/2014 / O / 19/12/2014 / P, O
MEKINIST / Trametinib / Antineoplastic and immunomodulating agents / Yes / 30/06/2014 / 29/05/2013 / O
MIRCERA / methoxy polyethylene glycol-epoetin beta / Blood and blood forming organs / No / 20/07/2007 / 14/11/2007
MOVENTIG / naloxegol / Alimentary tract and metabolism / No / 08/12/2014 / 16/09/2014
MOZOBIL / plerixafor / Antineoplastic and immunomodulating agents / Yes / 31/07/2009 / O / 15/12/2008 / P, O
MULTAQ / dronedarone / Cardiovascular system / No / 26/11/2009 / 07/01/2009 / P
MYCAMINE / micafungin / Anti-infectives for systemic use / No / 25/04/2008 / 16/03/2005 / P
NEVANAC / nepafenac / Sensory organs / No / 11/12/2007 / 19/08/2005 / P
NPLATE / romiplostim / Blood and blood forming organs / Yes / 04/02/2009 / O / 22/08/2008 / P, O
NULOJIX /
belatacept
/ Antineoplastic and immunomodulating agents / No / 17/06/2011 / 15/06/2011 / P, O
OFEV / nintedanib / Antineoplastic and immunomodulating agents / No / 15/01/2015 / A, O / 15/10/2014 / P, O
OLYSIO / simeprevir / Anti-infectives for systemic use / No / 14/05/2014 / 22/11/2013 / P
ONBREZ BREEZHALER / indacaterol maleate / Respiratory system / No / 30/11/2009 / 01/07/2011
ONGLYZA / saxagliptin / Alimentary tract and metabolism / No / 01/10/2009 / 31/07/2009
OPDIVO / Nivolumab / Antineoplastic and immunomodulating agents / Yes / 19/06/2015 / A / 22/12/2014 / P,O
OPSUMIT /
macitentan
/ Cardiovascular system / No / 20/12/2013 / O / 18/10/2013 / O
ORBACTIV / oritavancin / Anti-infectives for systemic use / No / 19/03/2015 / 06/08/2014 / P
ORENCIA / abatacept / Antineoplastic and immunomodulating agents / Yes / 21/05/2007 / 23/12/2005 / P
ORPHACOL / cholic acid / Alimentary tract and metabolism / Yes / 12/09/2013 / O / 17/03/2015 / P, O
OTEZLA / apremilast / Antineoplastic and immunomodulating agents / No / 15/01/2015 / 21/03/2014
PERJETA / pertuzumab / Antineoplastic and immunomodulating agents / Yes / 04/03/2013 / 08/06/2012 / P
PICATO / ingenol mebutate / Dermatologicals / No / 15/11/2012 / 23/01/2012
PLEGRIDY / peginterferon beta-1a / Antineoplastic and immunomodulating agents / No / 18/07/2014 / 15/08/2014
PRADAXA / dabigatran / Blood and blood forming organs / No / 18/03/2008 / 19/10/2010 / P
PREZISTA / darunavir / Anti-infectives for systemic use / Yes / 12/02/2007 / 23/06/2006 / P
PROLIA /
denosumab
/ Musculoskeletal system / No / 26/05/2010 / 01/06/2010
QUTENZA / capsaicin / Nervous system / No / 15/05/2009 / 16/11/2009 / O
RAPISCAN / regadenoson / Cardiovascular system / No / 06/09/2010 / 10/04/2008
RANEXA / ranolazine / Cardiovascular system / No / 09/07/2008 / 27/01/2006
RASILEZ /
aliskiren
/ Cardiovascular system / No / 22/08/2007 / 05/03/2007
RELISTOR / methylnaltrexone / Alimentary tract and metabolism / No / 02/07/2008 / 24/04/2008
REVESTIVE / teduglutide / Alimentary tract and metabolism / Yes / 30/08/2012 / O / 21/12/2012 / O
REVOLADE / eltrombopag olamine / Blood and blood forming organs / Yes / 11/03/2010 / 20/11/2008 / P, O
REVLIMID /
lenalidomide / Antineoplastic and immunomodulating agents / Yes / 14/06/2007 / 27/12/2005 / P, O
ROACTEMRA / tocilizumab / Antineoplastic and immunomodulating agents / Yes / 16/01/2009 / 02/01/2010
SAMSCA /
tolvaptan
/ Cardiovascular system / No / 03/08/2009 / 19/05/2009
SEBIVO / telbivudine / Anti-infectives for systemic use / No / 24/04/2007 / 25/10/2006
SIGNIFOR / pasireotide / Systemic hormonal preparations / No / 24/02/2012 / O / 14/12/2012 / O
SIMPONI / golimumab / Antineoplastic and immunomodulating agents / No / 01/10/2009 / 24/04/2009
SIRTURO / bedaquiline / Anti-infectives for systemic use / Yes / 05/03/2014 / O / 28/12/2012 / P, O
SIVEXTRO / tedizolid / Anti-infectives for systemic use / No / 23/03/2015 / 20/06/2014 / P
SOLIRIS / eculizumab / Antineoplastic and immunomodulating agents / Yes / 20/06/2007 / A, O / 16/03/2007 / P, O
SOVALDI / sofosbuvir / Anti-infectives for systemic use / Yes / 16/01/2014 / A / 06/12/2013 / P
STELARA /
ustekinumab
/ Antineoplastic and immunomodulating agents / No / 16/01/2009 / 25/09/2009
STIVARGA /
regorafenib
/ Antineoplastic and immunomodulating agents / No / 26/08/2013 / A / 27/09/2012 / P
STRIBILD / elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil fumarate / Anti-infectives for systemic use / No / 24/05/2013 / 28/07/2012
SYCREST / asenapine / Nervous system / No / 01/09/2010 / 13/08/2009
SYLVANT /
siltuximab
/ Antineoplastic and immunomodulating agents / No / 22/05/2014 / A, O / 23/04/2014 / P, O
TASIGNA / nilotinib / Antineoplastic and immunomodulating agents / Yes / 19/11/2007 / O / 29/10/2007 / O
TAFINLAR / dabrafenib / Antineoplastic and immunomodulating agents / No / 26/08/2013 / 29/05/2013 / O
TECFIDERA / dimethyl fumarate / Nervous system / No / 30/01/2014 / 27/03/2013
TIVICAY /
dolutegravir
/ Anti-infectives for systemic use / Yes / 16/01/2014 / 12/08/2013 / P
TORISEL / temsirolimus / Antineoplastic and immunomodulating agents / Yes / 19/11/2007 / O / 30/05/2007 / P, O
TOVIAZ / fesoterodine / Genito-urinary system and sex hormones / No / 20/04/2007 / 31/10/2008
TRAJENTA / linagliptin / Alimentary tract and metabolism / No / 24/08/2011 / 02/05/2011
TRESIBA / insulin degludec / Alimentary tract and metabolism / No / 21/01/2013 / 25/09/2015
TROBALT / retigabine / Nervous system / No / 28/03/2011 / 10/06/2011
TRULICITY / dulaglutide / Alimentary tract and metabolism / No / 21/11/2014 / 18/09/2014
TYVERB /
lapatinib
/ Antineoplastic and immunomodulating agents / Yes / 10/06/2008 / 13/03/2007 / P
UROREC / silodosin / Genito-urinary system and sex hormones / No / 29/01/2010 / 08/10/2008
VECTIBIX / panitumumab / Antineoplastic and immunomodulating agents / No / 03/12/2007 / 27/09/2006 / P
VICTOZA / Liraglutide / Alimentary tract and metabolism / No / 30/06/2009 / 25/01/2010
VICTRELIS / boceprevir / Anti-infectives for systemic use / Yes / 18/07/2011 / A / 13/05/2011 / P
VIDAZA / azacitidine / Antineoplastic and immunomodulating agents / Yes / 17/12/2008 / A, O / 19/05/2004 / P, O
VIEKIRAX / ombitasvir / paritaprevir / ritonavir / Anti-infectives for systemic use / No / 15/01/2015 / A / 19/12/2014 / P
VIMIZIM / recombinant human n-acetylgalactosamine-6-sulfatase (rhgalns) / Alimentary tract and metabolism / Yes / 28/04/2014 / A, O / 14/12/2014 / P, O
VIMPAT / lacosamide / Nervous system / No / 29/08/2008 / 28/10/2008
VIPIDIA / alogliptin / Alimentary tract and metabolism / No / 19/09/2013 / 25/01/2013
VOLIBRIS / ambrisentan / Cardiovascular system / No / 21/04/2008 / O / 15/06/2007 / P, O
VOTRIENT / pazopanib / Antineoplastic and immunomodulating agents / No / 14/06/2010 / 19/10/2009
VPRIV /
velaglucerase alfa / Alimentary tract and metabolism / No / 26/08/2010 / A, O / 26/02/2010 / P, O
XALKORI / crizotinib / Antineoplastic and immunomodulating agents / Yes / 23/10/2012 / 26/08/2011 / P, O
XARELTO / Rivaroxaban / Blood and blood forming organs / No / 30/08/2008 / 01/07/2011
XIAPEX / collagenase Clostridium histolyticum / Musculoskeletal system / No / 28/02/2011 / 02/02/2010 / P, O
XOFIGO / radium Ra223 dichloride / Various / No / 13/11/2013 / A / 29/05/2013 / P
XTANDI / enzalutamide / Antineoplastic and immunomodulating agents / Yes / 21/06/2013 / 31/08/2012 / P
YERVOY / Ipilizumab / Antineoplastic and immunomodulating agents / No / 13/07/2011 / 25/03/2011 / P, O
YONDELIS / trabectedin / Antineoplastic and immunomodulating agents / No / 17/09/2007 / O / 23/10/2015 / P
ZALTRAP / aflibercept / Antineoplastic and immunomodulating agents / No / 01/02/2013 / 03/08/2012 / P
ZEBINIX /
eslicarbazepine
/ Nervous system / No / 21/04/2009 / 08/11/2013
ZELBORAF / vemurafenib / Antineoplastic and immunomodulating agents / Yes / 17/02/2012 / A / 17/08/2011 / P, O
ZINFORO /
ceftaroline
/ Anti-infectives for systemic use / No / 23/08/2012 / 29/10/2010
ZONTIVITY / vorapaxar / Blood and blood forming organs / No / 19/01/2015 / 08/05/2014
ZYCADIA / ceritinib / Antineoplastic and immunomodulating agents / No / 06/05/2015 / 29/04/2014 / P, O
ZYDELIG / idelalisib / Antineoplastic and immunomodulating agents / Yes / 18/09/2014 / A / 23/07/2014 / O
ZYTIGA / abiraterone / Antineoplastic and immunomodulating agents / Yes / 05/09/2011 / A / 258/04/2011 / P