PMDA审查报告*英文

PMDA药品审评报告，英文版本。

The following English translations of review reports are intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese originals and the translations, the former shall prevail. PMDA shall not be responsible for any consequence resulting from use of the English versions.

The review reports were selected for translation among those of drugs with a new active ingredient that recently received marketing approval, in consideration of relevant factors including the novelty and priority.

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A

Brand Name	Non-proprietary Name	Approved In	English	Japanese
Abraxane Partial Change Approval	paclitaxel	September  2019
Acoalan	antithrombin gamma (genetical recombination)	July 2015
Acofide	acotiamide hydrochloride hydrate	March 2013
Actair	–	March 2015		1.  2.
Actemra Initial Approval	tocilizumab (genetical recombination)	April 2008		1.  2.
Actemra Partial Change Approval	tocilizumab (genetical recombination)	June 2017
Actemra Partial Change Approval	tocilizumab (genetical recombination)	August 2017
Actemra Partial Change Approval	tocilizumab (genetical recombination)	May 2019
Adcetris Initial Approval	brentuximab vedotin (genetical recombination)	January 2014
Adcetris Partial Change Approval	brentuximab vedotin (genetical recombination)	September 2018
Adcetris Partial Change Approval	brentuximab vedotin (genetical recombination)	December 2019
Adempas	riociguat	January 2014
Adlumiz	anamorelin hydrochloride	January 2021
Adsorbed Cell Culture-derived Influenza Vaccine H5N1 “Kitasato Daiichi Sankyo”	adsorbed cell culture-derived influenza vaccine (H5N1)	March 2016
Adsorbed Influenza Vaccine (H5N1)  “HOKKEN”	adsorbed influenza vaccine (H5N1)	October 2007		1.  2.  3.
Adsorbed Influenza Vaccine (H5N1)  “BIKEN”	adsorbed influenza vaccine (H5N1)	October 2007		1.  2.  3.
Adynovate	rurioctocog alfa pegol (genetical recombination)	March 2016
Afstyla	lonoctocog alfa (genetical recombination)	September 2017
Akalux	cetuximab sarotalocan sodium (genetical recombination)	September 2020
Alabel/Alaglio	aminolevulinic acid hydrochloride	March 2013
Alecensa	alectinib hydrochloride	July 2014
Allergen Scratch Extract Positive control “TORII” Histamine Dihydrochloride	histamine dihydrochloride	September 2015
Amenalief	amenamevir	July 2017
Anoro Ellipta	umeclidinium bromide/ vilanterol trifenatate	July 2014
Artist	carvedilol	August 2015
Avastin Initial Approval	bevacizumab (genetical recombination)	April 2007		1.  2.  3.  4.  5.  6.
Avastin Partial Change Approval	bevacizumab (genetical recombination)	May 2016
Avigan	favipiravir	March 2014

Brand NameNon-proprietary NameApproved InEnglishJapaneseBavencioavelumab (genetical recombination)September 2017Benlysta
^{Initial Approval}belimumab (genetical recombination)September 2017Benlysta
^{Partial Change Approval}belimumab (genetical recombination)September 2019BetanismirabegronJune 2011Bevespi Aerosphereglycopyrronium bromide/formoterol fumarate hydrateJune 2019Biktarvybictegravir sodium/emtricitabine/tenofovir alafenamide fumarateMarch 2019Botoxbotulinum toxin type AJune 2015Braftovi
^{Initial Approval}encorafenibJanuary 2019Braftovi
^{Partial Change Approval}encorafenibNovember 2020Breztri Aerospherebudesonide/glycopyrronium bromide/formoterol fumarate hydrateJune 2019Bridionsugammadex sodiumJanuary 2010

Brand NameNon-proprietary NameApproved InEnglishJapaneseCerdartolen-January 2014Cerdelgaeliglustat tartrateMarch 2015
*Cervarixrecombinant adsorbed bivalent human papillomavirus-like particle vaccine (derived from Trichoplusia ni cell)October 2009ClenafinefinaconazoleJuly 2014ClozarilclozapineApril 2009Comirnaty
(Report on Special Approval for Emergency)
^{Initial Approval}Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2)
(active ingredient: tozinameran)February 2021Comirnaty
(Report on Special Approval for Emergency)
^{Partial Change Approval}Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2)
(active ingredient: tozinameran)November 2021Copegus
^{Partial Change Approval}ribavirinMarch 2015Copegus
^{Partial Change Approval}ribavirinMarch 2017CorectimdelgocitinibJanuary 2020Cosentyx
^{Initial Approval}secukinumab (genetical recombination)December 2014Cosentyx
^{Partial Change Approval}secukinumab (genetical recombination)December 2015Crysvitaburosumab (genetical recombination)September 2019Cymbalta
^{Partial Change Approval}duloxetine hydrochlorideDecember 2016Cyramza
^{Initial Approval}ramucirumab (genetical recombination)March 2015Cyramza
^{Partial Change Approval}ramucirumab (genetical recombination)May 2016Cyramza
^{Partial Change Approval}ramucirumab (genetical recombination)June 2016

* Errata sheet. The English translation has been corrected accordingly.

Brand NameNon-proprietary NameApproved InEnglishJapaneseDaklinzadaclatasvir hydrochlorideJuly 2014Darzalex
^{Initial Approval}daratumumab (genetical recombination)September 2017Darzalex
^{Partial Change Approval}daratumumab (genetical recombination)August 2019DayvigolemborexantJanuary 20201.
2.DeltybadelamanidJuly 2014Diquasdiquafosol sodiumApril 2010 1.
 2.Duacclindamycin phosphate hydrate/benzoyl peroxideMarch 2015Dupixentdupilumab (genetical recombination)January 2018

Brand NameNon-proprietary NameApproved InEnglishJapaneseEfientprasugrel hydrochlorideMarch 2014 1.
 2.EliquisapixabanDecember 2012
*Emplicitielotuzumab (genetical recombination)September 2016Emulsion-adjuvanted Cell-culture Derived Influenza HA Vaccine (Prototype) for Intramuscular Injection “KAKETSUKEN”emulsion-adjuvanted cell-culture derived influenza HA vaccine (prototype)March 2015EnaroyenarodustatSeptember 2020Enhertu
^{Initial Approval}trastuzumab deruxtecan (genetical recombination)March 2020Enhertu
^{Partial Change Approval}trastuzumab deruxtecan (genetical recombination)September 2020Enspryngsatralizumab (genetical recombination)June 2020
*Epoprostenol ACT
^{Partial Change Approval}epoprostenol sodiumMarch 2017ErelsaelbasvirSeptember 2016ErleadaapalutamideMarch 2019Evenityromosozumab (genetical recombination)January 2019EvrenzoroxadustatSeptember 2019Eyleaaflibercept (genetical recombination)June 2015

* Errata sheet. The English translation has been corrected accordingly.

F

Brand Name	Non-proprietary Name	Approved In	English	Japanese
Farydak	panobinostat lactate	July 2015
Fasenra	benralizumab (genetical recombination)	January 2018
Feburic Initial Approval	febuxostat	January 2011
Feburic Partial Change Approval	febuxostat	May 2016
Forteo	teriparatide (genetical recombination)	July 2010
Forxiga	dapagliflozin propylene glycolate hydrate	March 2014

Brand NameNon-proprietary NameApproved InEnglishJapaneseGalafoldmigalastat hydrochlorideMarch 2018Geninaxgarenoxacin mesilate hydrateJuly 2007 1.
 2.Genvoyaelvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarateJune 2016Giotrifafatinib maleateJanuary 2014Gooficeelobixibat hydrateJanuary 2018 1.
 2.Grazynagrazoprevir hydrateSeptember 2016

Brand NameNon-proprietary NameApproved InEnglishJapaneseHalaven
^{Initial Approval}eribulin mesilateApril 2011Halaven
^{Partial Change Approval}eribulin mesilateFebruary 2016Harvoniledipasvir acetonate/sofosbuvirJuly 2015Hemangiolpropranolol hydrochlorideJuly 2016Hemlibraemicizumab (genetical recombination)March 2018Humira
^{Partial Change Approval}adalimumab (genetical recombination)September 2016

Brand NameNon-proprietary NameApproved InEnglishJapaneseIdelvionalbutrepenonacog alfa (genetical recombination)September 2016Ilaris
^{Partial Change Approval}canakinumab (genetical recombination)December 2016Imfinzi
^{Initial Approval}durvalumab (genetical recombination)July 2018Imfinzi
^{Partial Change Approval}durvalumab (genetical recombination)August 2020Inavir
^{Initial Approval}laninamivir octanoate hydrateSeptember 2010Inavir
^{Partial Change Approval}laninamivir octanoate hydrateDecember 2013Inavir
^{Partial Change Approval}laninamivir octanoate hydrateAugust 2016Inavir
^{Partial Change Approval}laninamivir octanoate hydrateJune 2019Insulin Glargine BS [Lilly]insulin glargine (genetical recombination) [insulin glargine biosimilar 1]December 2014Intuniv
^{Partial Change Approval}guanfacine hydrochlorideJune 2019Irribowramosetron hydrochlorideMay 2015Isentressraltegravir potassiumJune 2008IstodaxromidepsinJuly 2017Izcargopabinafusp alfa (genetical recombination)March 2021

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J

Brand Name	Non-proprietary Name	Approved In	English	Japanese
Januvia/Glactiv	sitagliptin phosphate hydrate	October 2009		1.  2.
Jivi	damoctocog alfa pegol (genetical recombination)	September 2018

Brand NameNon-proprietary NameApproved InEnglishJapaneseKadcylatrastuzumab emtansine (genetical recombination)September 2013Kanumasebelipase alfa (genetical recombination)March 2016Kenketu Glovenin-I
^{Partial Change Approval}freeze-dried polyethylene glycol-treated human normal immunoglobulinNovember 2015Kenketu Glovenin-I
^{Partial Change Approval}freeze-dried polyethylene glycol-treated human normal immunoglobulinSeptember 2016Kevzarasarilumab (genetical recombination)September 2017Keytruda
^{Initial Approval}pembrolizumab (genetical recombination)September 2016Keytruda
^{Partial Change Approval}pembrolizumab (genetical recombination)December 2016Keytruda
^{Partial Change Approval}pembrolizumab (genetical recombination)December 2018KyproliscarfilzomibJuly 2016

Brand NameNon-proprietary NameApproved InEnglishJapaneseLagevrio
(Report on Special Approval for Emergency)molnupiravirDecember 2021Laserphyrintalaporfin sodiumMay 2015Lenvima
^{Initial Approval}lenvatinib mesilateMarch 2015 1.
 2.
 3.
 4.Lenvima
^{Partial Change Approval}lenvatinib mesilateMarch 20181.
2.Livalopitavastatin calcium hydrateJune 2015LixianaedoxabanApril 2011
*Lonsurf
^{Initial Approval}trifluridine and tipiracil hydrochlorideMarch 2014Lonsurf
^{Partial Change Approval}trifluridine and tipiracil hydrochlorideAugust 2019Loqoaesflurbiprofen/mentha oilSeptember 2015LorbrenalorlatinibSeptember 2018Lumicefbrodalumab (genetical recombination)July 2016LyxumialixisenatideJune 2013

* Errata sheet. The English translation has been corrected accordingly.

M

Brand Name	Non-proprietary Name	Approved In	English	Japanese
Macugen	pegaptanib sodium	July 2008
Maviret	glecaprevir hydrate/pibrentasvir	September 2017
Mayzent	siponimod fumaric acid	June 2020		*
Mekinist Initial Approval	trametinib dimethyl sulfoxide	March 2016
Mekinist Partial Change Approval	trametinib dimethyl sulfoxide	March 2018
Mekinist Partial Change Approval	trametinib dimethyl sulfoxide	July 2018
Mektovi Initial Approval	binimetinib	January 2019
Mektovi Partial Change Approval	binimetinib	November 2020
Memary	memantine hydrochloride	January 2011
Metreleptin	metreleptin (genetical recombination)	March 2013
Mikeluna	carteolol hydrochloride/ latanoprost	September 2016
Minnebro	esaxerenone	January 2019
Miticure	–	September 2015
Mulpleta	lusutrombopag	September 2015		1.  2.
Mundesine	forodesine hydrochloride	March 2017
Myozyme	alglucosidase alfa (genetical recombination)	April 2007		1.  2.

* Errata sheet. The English translation has been corrected accordingly.

N

Brand Name	Non-proprietary Name	Approved In	English	Japanese
Ninlaro	ixazomib citrate	March 2017
Nopicor	nalfurafine hydrochloride	December 2014
Nouriast	istradefylline	March 2013
NovoEight	turoctocog alfa (genetical recombination)	January 2014
NovoThirteen	catridecacog (genetical recombination)	March 2015
Nubeqa	darolutamide	January 2020
Nucala	mepolizumab (genetical recombination)	March 2016

Brand NameNon-proprietary NameApproved InEnglishJapaneseOfev
^{Initial Approval}nintedanib ethanesulfonateJuly 2015Ofev
^{Partial Change Approval}nintedanib ethanesulfonateMay 2020Olanedineolanexidine gluconateJuly 2015Olumiant
^{Initial Approval}baricitinibJuly 2017Olumiant
^{Partial Change Approval}baricitinibDecember 2020Olumiant
^{Partial Change Approval}baricitinibApril 2021OngentysopicaponeJune 2020Opdivo
^{Initial Approval}nivolumab (genetical recombination)July 2014Opdivo
^{Partial Change Approval}nivolumab (genetical recombination)December 2015Opdivo
^{Partial Change Approval}nivolumab (genetical recombination)August 2016Opdivo
^{Partial Change Approval}nivolumab (genetical recombination)December 2016Opdivo
^{Partial Change Approval}nivolumab (genetical recombination)March 2017Opdivo
^{Partial Change Approval}nivolumab (genetical recombination)September 2017Opdivo
^{Partial Change Approval}nivolumab (genetical recombination)May 2018Opdivo
^{Partial Change Approval}nivolumab (genetical recombination)August 2018Opdivo
^{Partial Change Approval}nivolumab (genetical recombination)February 2020Opdivo
^{Partial Change Approval}nivolumab (genetical recombination)September 2020Orenciaabatacept (genetical recombination)July 2010OrfadinnitisinoneDecember 2014Orkedia
^{Initial Approval}evocalcetMarch 2018Orkedia
^{Partial Change Approval}evocalcetDecember 2019Orladeyoberotralstat hydrochlorideJanuary 2021OtezlaapremilastDecember 2016

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P

Brand Name	Non-proprietary Name	Approved In	English	Japanese
Parmodia	pemafibrate	July 2017
Parsabiv	etelcalcetide hydrochloride	December 2016
Perjeta	pertuzumab (genetical recombination)	June 2013		*
Pirespa	pirfenidone	October 2008
Pomalyst	pomalidomide	March 2015
Poteligeo Initial Approval	mogamulizumab (genetical recombination)	March 2012
Poteligeo Partial Change Approval	mogamulizumab (genetical recombination)	August 2018
Pradaxa	dabigatran etexilate methanesulfonate	January 2011
Pralia Partial Change Approval	denosumab (genetical recombination)	July 2017
Praluent	alirocumab (genetical recombination)	July 2016		*
Prevymis	letermovir	March 2018
Prizbind	idarucizumab (genetical recombination)	September 2016
Proemend	fosaprepitant meglumine	March 2016

* Errata sheet. The English translation has been corrected accordingly.Back to Top

Q

Brand Name	Non-proprietary Name	Approved In	English	Japanese
Quattrovac	adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain) combined vaccine	July 2012		1.  2.

Brand NameNon-proprietary NameApproved InEnglishJapaneseRadicutedaravoneJune 2015Rapalimus
(tablet)sirolimusJuly 2014Rapalimus
(topical gel)sirolimusMarch 2018Rapiactaperamivir hydrateJanuary 2010Rasilezaliskiren fumarateJuly 2009Rasuritekrasburicase (genetical recombination)October 2009Rebetol
^{Partial Change Approval}ribavirinSeptember 2016Rebetol
^{Partial Change Approval}ribavirinMarch 2017Refixianonacog beta pegol (genetical recombination)July 2018Regrothtrafermin (genetical recombination)September 2016ReluminarelugolixJanuary 2019Remicadeinfliximab (genetical recombination)August 2015Remitchnalfurafine hydrochlorideJanuary 2009Repathaevolocumab (genetical recombination)January 2016Revcovielapegademase (genetical recombination)March 2019Revlimid
^{Partial Change Approval}lenalidomide hydrateMarch 2017Revolade
^{Initial Approval}eltrombopag olamineOctober 2010Revolade
^{Partial Change Approval}eltrombopag olamineAugust 2017RisperdalrisperidoneFebruary 2016Rituxanrituximab (genetical recombination)August 2014Romiplate
^{Initial Approval}romiplostim (genetical recombination)January 2011Romiplate
^{Partial Change Approval}romiplostim (genetical recombination)June 2019Ronapreve
(Report on Special Approval for Emergency)
^{Initial Approval}casirivimab (genetical recombination) and imdevimab (genetical recombination)July 2021Ronapreve
(Report on Special Approval for Emergency)
^{Partial Change Approval}casirivimab (genetical recombination) and imdevimab (genetical recombination)November 2021Rosuzetezetimibe / rosuvastatin calciumMarch 2019RozeremramelteonApril 2010RozlytrekentrectinibJune 2019Ryzodeginsulin degludec (genetical recombination) / insulin aspart (genetical recombination)December 2012

Brand NameNon-proprietary NameApproved InEnglishJapaneseSamscatolvaptanMarch 2014Sarclisaisatuximab (genetical recombination)June 2020Seebriglycopyrronium bromideSeptember 2012Shingrixdried recombinant herpes zoster vaccine (derived from Chinese hamster ovary cells)March 2018Signifor
^{Partial Change Approval}pasireotide pamoateMarch 2018Skyrizirisankizumab (genetical recombination)March 2019Smyrafpeficitinib hydrobromideMarch 2019Soliris^{Initial Approval}eculizumab (genetical recombination)April 2010Soliris
^{Partial Change Approval}eculizumab (genetical recombination)December 2017Sovaldi
^{Initial Approval}sofosbuvirMarch 2015Sovaldi
^{Partial Change Approval}sofosbuvirMarch 2017Sovriadsimeprevir sodiumSeptember 2013Spikevax (previously COVID-19 Vaccine Moderna)
(Report on Special Approval for Emergency)
^{Initial Approval}Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2)May 2021Spinraza
^{Initial Approval}nusinersen sodiumJuly 2017Spinraza
^{Partial Change Approval}nusinersen sodiumSeptember 2017Spioltotiotropium bromide hydrate/olodaterol hydrochlorideSeptember 2015Squarekidsadsorbed diphtheria-purified pertussis-tetanus-inactivated polio (salk vaccine) combined vaccineJuly 2014Steboronineborofalan (¹⁰B)March 2020Stelara
^{Initial Approval}ustekinumab (genetical recombination)December 2010Stelara
^{Partial Change Approval}ustekinumab (genetical recombination)March 2017Stivarga
^{Initial Approval}regorafenib hydrateMarch 2013Stivarga
^{Partial Change Approval}regorafenib hydrateJune 2017Strensiqasfotase alfa (genetical recombination)July 2015Stribildelvitegravir/cobicistat/
emtricitabine/tenofovir disoproxil fumarateMarch 2013Suglat
^{Initial Approval}ipragliflozin L-prolineJanuary 2014Suglat
^{Partial Change Approval}ipragliflozin L-prolineDecember 2018SuinyanagliptinDecember 2015SunvepraasunaprevirJuly 2014Symproicnaldemedine tosilateMarch 2017Synflorixpneumococcal 10-valent conjugate vaccine adsorbed (non-typeable haemophilus influenzae [NTHi] protein D, diphtheria or tetanus toxoid conjugates)March 2015

Brand NameNon-proprietary NameApproved InEnglishJapaneseTabrectacapmatinib hydrochloride hydrateJune 2020Tafinlar
^{Initial Approval}dabrafenib mesilateMarch 2016Tafinlar
^{Partial Change Approval}dabrafenib mesilateMarch 2018Tafinlar
^{Partial Change Approval}dabrafenib mesilateJuly 2018Tagrissoosimertinib mesilateMarch 2016Takecabvonoprazan fumarateDecember 2014Takeldaaspirin/lansoprazoleMarch 2014Talionbepotastine besilateMay 2015Taltzixekizumab (genetical recombination)July 2016Tecentriq
^{Initial Approval}atezolizumab (genetical recombination)January 2018Tecentriq
^{Partial Change Approval}atezolizumab (genetical recombination)August 2019Tecentriq
_{Partial Change Approval}atezolizumab (genetical recombination)September 2019Tecentriq
^{Partial Change Approval}atezolizumab (genetical recombination)November 2019Teneliateneligliptin hydrobromide hydrateJune 2012Tepmetkotepotinib hydrochloride hydrateMarch 2020Tetrabikadsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain) combined vaccineJuly 2012 1.
 2.ThaledthalidomideOctober 2008Tivicaydolutegravir sodiumMarch 2014Topiloric/UriadectopiroxostatJune 2013TopinatopiramateJuly 2007Tracleer (pediatric dispersible tablets)bosentan hydrateSeptember 2015Treakisym
^{Partial Change Approval}bendamustine hydrochlorideDecember 2016Tremfyaguselkumab (genetical recombination)March 2018Trerief
^{Initial Approval}zonisamideJanuary 2009Trerief
^{Partial Change Approval}zonisamideJuly 2018Tresiba
^{Initial Approval}insulin degludec (genetical recombination)September 2012Tresiba
^{Partial Change Approval}insulin degludec (genetical recombination)August 2015

Brand NameNon-proprietary NameApproved InEnglishJapaneseUptraviselexipagSeptember 2016

Brand NameNon-proprietary NameApproved InEnglishJapaneseVafseovadadustatJune 2020Vanflytaquizartinib hydrochlorideJune 2019Vaxzevria
(Report on Special Approval for Emergency)COVID-19 (SARS-CoV-2) Vaccine (recombinant chimpanzee adenovirus vector)May 2021Veklury
(Report on Special Approval for Emergency)remdesivirMay 2020
*Velcade
^{Partial Change Approval}bortezomibAugust 2019Velexbru
^{Initial Approval}tirabrutinib hydrochlorideMarch 2020Velexbru
^{Partial Change Approval}tirabrutinib hydrochlorideAugust 2020
*Vemlidytenofovir alafenamide fumarateDecember 2016Victozaliraglutide (genetical recombination)January 2010Viekirax
^{Initial Approval}ombitasvir hydrate/paritaprevir hydrate/ritonavirSeptember 2015Viekirax
^{Partial Change Approval}ombitasvir hydrate/paritaprevir hydrate/ritonavirSeptember 2016ViltepsoviltolarsenMarch 2020Vizimprodacomitinib hydrateJanuary 2019Votrientpazopanib hydrochlorideSeptember 2012Vyndaqel
^{Initial Approval}tafamidis meglumineSeptember 2013Vyndaqel
^{Partial Change Approval}tafamidis meglumineMarch 2019
*

* Errata sheet. The English translation has been corrected accordingly.

Brand NameNon-proprietary NameApproved InEnglishJapaneseXalkori
^{Initial Approval}crizotinibMarch 2012Xalkori
^{Partial Change Approval}crizotinibMay 2017Xeljanz
^{Initial Approval}tofacitinib citrateMarch 2013Xeljanz
^{Partial Change Approval}tofacitinib citrateMay 2018Xevudy (Report on Special Approval for Emergency)sotrovimab (genetical recombination)September 2021
*Xiaflexcollagenase (clostridium histolyticum)July 2015Ximencydaclatasvir hydrochloride/asunaprevir/beclabuvir hydrochlorideDecember 2016Xofluzabaloxavir marboxilFebruary 20181.
2.
3.Xolairomalizumab (genetical recombination)January 2009Xospatagilteritinib fumarateSeptember 2018

* Errata sheet. The English translation has been corrected accordingly.

Y

Brand Name	Non-proprietary Name	Approved In	English	Japanese
Yervoy Initial Approval	ipilimumab (genetical recombination)	July 2015
Yervoy Partial Change Approval	ipilimumab (genetical recombination)	May 2018
Yervoy Partial Change Approval	ipilimumab (genetical recombination)	August 2018
Yervoy Partial Change Approval	ipilimumab (genetical recombination)	September 2020
Yondelis	trabectedin	September 2015

Brand NameNon-proprietary NameApproved InEnglishJapaneseZafatektrelagliptin succinateMarch 2015ZagallodutasterideSeptember 2015ZetiaezetimibeApril 2007ZykadiaceritinibMarch 2016Zyprexa/OlanzapineolanzapineDecember 2017