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FDA drug approvals in 2023

FDA approved the original submission of 135 new drug and biologics license applications in 2023, from 101 sponsors. FDA marks 7 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

Approved	Brand	Ingredient	Sponsor	Application
December 22, 2023	ABACAVIR SULFATE AND LAMIVUDINE	abacavir sulfate, lamivudine	PHARMOBEDIENT	NDA204311
December 21, 2023	WAINUA (AUTOINJECTOR)	eplontersen sodium	ASTRAZENECA AB	NDA217388
December 18, 2023	FILSUVEZ	birch triterpenes	CHIESI	NDA215064
December 15, 2023	ZORYVE	roflumilast	ARCUTIS	NDA217242
December 14, 2023	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	HIKMA	NDA217812
December 13, 2023	IDOSE TR	travoprost	GLAUKOS	NDA218010
December 13, 2023	IWILFIN	eflornithine hydrochloride	USWM	NDA215500
December 6, 2023	AVZIVI	bevacizumab-tnjn	BIO-THERA SOLUTIONS LTD	BLA761198
December 5, 2023	FABHALTA	iptacopan hydrochloride	NOVARTIS	NDA218276
December 5, 2023	PHYRAGO	dasatinib	HANDA THERAP	NDA216099
November 29, 2023	ALVAIZ	eltrombopag choline	TEVA PHARMS INC	NDA216774
November 27, 2023	OGSIVEO	nirogacestat hydrobromide	SPRINGWORKS	NDA217677
November 16, 2023	RYZNEUTA	efbemalenograstim alfa-vuxw	EVIVE BIOTECHNOLOGY	BLA761134
November 16, 2023	TRUQAP	capivasertib	ASTRAZENECA	NDA218197
November 15, 2023	AUGTYRO	repotrectinib	BRISTOL	NDA218213
November 15, 2023	DEFENCATH	heparin sodium, taurolidine	CORMEDIX	NDA214520
November 8, 2023	FRUZAQLA	fruquintinib	TAKEDA PHARMS USA	NDA217564
November 8, 2023	ZEPBOUND	tirzepatide	ELI LILLY AND CO	NDA217806
November 3, 2023	ZITUVIMET	metformin hydrochloride, sitagliptin	ZYDUS LIFESCIENCES	NDA216743
November 1, 2023	VOQUEZNA	vonoprazan fumarate	PHATHOM	NDA215151
October 31, 2023	WEZLANA	ustekinumab-auub	AMGEN INC	BLA761285
October 31, 2023	WEZLANA	ustekinumab-auub	AMGEN INC	BLA761331
October 27, 2023	LOQTORZI	toripalimab-tpzi	COHERUS BIOSCIENCES INC	BLA761240
October 26, 2023	AGAMREE	vamorolone	CATALYST PHARMS	NDA215239
October 26, 2023	OMVOH	mirikizumab-mrkz	ELI LILLY AND CO	BLA761279
October 20, 2023	CABTREO	adapalene, benzoyl peroxide, clindamycin phosphate	BAUSCH	NDA216632
October 20, 2023	COXANTO	oxaprozin	SOLUBIOMIX	NDA217927
October 20, 2023	ROZLYTREK	entrectinib	GENENTECH INC	NDA218550
October 20, 2023	ZYMFENTRA	infliximab-dyyb	CELLTRION	BLA761358
October 18, 2023	ZITUVIO	sitagliptin	ZYDUS LIFESCIENCES	NDA211566
October 17, 2023	BIMZELX	bimekizumab-bkzx	UCB INC	BLA761151
October 17, 2023	COMBOGESIC IV	acetaminophen, ibuprofen sodium	HIKMA	NDA215320
October 17, 2023	QLOSI	pilocarpine hydrochloride	ORASIS PHARMS	NDA217836
October 17, 2023	XPHOZAH	tenapanor hydrochloride	ARDELYX INC	NDA213931
October 17, 2023	ZILBRYSQ	zilucoplan sodium	UCB INC	NDA216834
October 12, 2023	VELSIPITY	etrasimod arginine	PFIZER	NDA216956
October 6, 2023	COSENTYX	secukinumab	NOVARTIS PHARMS CORP	BLA761349
September 29, 2023	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	micafungin sodium	BAXTER HLTHCARE CORP	NDA216142
September 29, 2023	RIVFLOZA	nedosiran sodium	NOVO	NDA215842
September 29, 2023	TECHNEGAS KIT	technetium tc-99m labeled carbon	CYCLOMEDICA	NDA022335
September 29, 2023	TOFIDENCE	tocilizumab-bavi	BIOGEN MA	BLA761354
September 29, 2023	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	vasopressin	BAXTER HLTHCARE CORP	NDA217569
September 28, 2023	OPFOLDA	miglustat	AMICUS THERAP US	NDA215211
September 28, 2023	POMBILITI	cipaglucosidase alfa-atga	AMICUS THERAP US	BLA761204
September 27, 2023	ENTYVIO	vedolizumab	TAKEDA PHARMS USA	BLA761133
September 26, 2023	BOSULIF	bosutinib monohydrate	PF PRISM CV	NDA217729
September 25, 2023	RYZUMVI	phentolamine mesylate	FAMYGEN LIFE SCI	NDA217064
September 22, 2023	EXXUA	gepirone hydrochloride	FABRE KRAMER	NDA021164
September 22, 2023	LIKMEZ	metronidazole	SAPTALIS PHARMS	NDA216755
September 15, 2023	OJJAARA	momelotinib dihydrochloride	GLAXOSMITHKLINE	NDA216873
September 12, 2023	CYCLOPHOSPHAMIDE	cyclophosphamide	SANDOZ	NDA217150
September 8, 2023	APHEXDA	motixafortide acetate	AYRMID PHARMA	NDA217159
September 7, 2023	XALKORI	crizotinib	PF PRISM CV	NDA217581
August 24, 2023	TYRUKO	natalizumab-sztn	SANDOZ INC	BLA761322
August 22, 2023	FOCINVEZ	fosaprepitant dimeglumine	STERISCIENCE	NDA216686
August 18, 2023	EYLEA HD	aflibercept	REGENERON PHARMACEUTICALS	BLA761355
August 18, 2023	IVRA	melphalan hydrochloride	APOTEX	NDA217110
August 18, 2023	VEOPOZ	pozelimab-bbfg	REGENERON PHARMACEUTICALS	BLA761339
August 16, 2023	SOHONOS	palovarotene	IPSEN	NDA215559
August 14, 2023	ELREXFIO	elranatamab	PFIZER INC	BLA761345
August 14, 2023	HEPZATO	melphalan hydrochloride	DELCATH SYSTEMS INC	NDA201848
August 11, 2023	AKEEGA	abiraterone acetate, niraparib tosylate	JANSSEN BIOTECH	NDA216793
August 9, 2023	TALVEY	talquetamab-tgvs	JANSSEN BIOTECH	BLA761342
August 4, 2023	IZERVAY	avacincaptad pegol sodium	ASTELLAS	NDA217225
August 4, 2023	ZURZUVAE	zuranolone	BIOGEN	NDA217369
July 28, 2023	RIVIVE	naloxone hydrochloride	HARM REDUCTION THERP	NDA217722
July 26, 2023	MEROPENEM	meropenem	HQ SPCLT PHARMA	NDA215212
July 24, 2023	XDEMVY	lotilaner	TARSUS	NDA217603
July 21, 2023	YCANTH	cantharidin	VERRICA PHARMS	NDA212905
July 20, 2023	VANFLYTA	quizartinib dihydrochloride	DAIICHI SANKYO INC	NDA216993
July 17, 2023	BEYFORTUS	nirsevimab-alip	ASTRAZENECA AB	BLA761328
June 27, 2023	CYCLOPHOSPHAMIDE	cyclophosphamide	BAXTER HLTHCARE CORP	NDA217651
June 27, 2023	NGENLA	somatrogon-ghla	PFIZER IRELAND PHARMACEUTICALS	BLA761184
June 26, 2023	RYSTIGGO	rozanolixizumab-noli	UCB INC	BLA761286
June 23, 2023	LITFULO	ritlecitinib tosylate	PFIZER	NDA215830
June 20, 2023	VYVGART HYTRULO	efgartigimod alfa and hyaluronidase-qvfc	ARGENX BV	BLA761304
June 16, 2023	LODOCO	colchicine	AGEPHA PHARMA FZ	NDA215727
June 15, 2023	COLUMVI	glofitamab-gxbm	GENENTECH INC	BLA761309
June 15, 2023	SUFLAVE	magnesium sulfate, polyethylene glycol 3350, potassium chloride, sodium chloride, sodium sulfate	AZURITY	NDA215344
June 7, 2023	FRINDOVYX	cyclophosphamide	AVYXA HOLDINGS	NDA210852
May 30, 2023	VEVYE	cyclosporine	HARROW EYE	NDA217469
May 26, 2023	INPEFA	sotagliflozin	LEXICON PHARMS INC	NDA216203
May 25, 2023	PAXLOVID (COPACKAGED)	nirmatrelvir, ritonavir	PFIZER	NDA217188
May 25, 2023	POSLUMA	flotufolastat f-18 gallium	BLUE EARTH	NDA216023
May 23, 2023	BRIXADI	buprenorphine	BRAEBURN	NDA210136
May 23, 2023	XACDURO (COPACKAGED)	durlobactam sodium, sulbactam sodium	ENTASIS THERAP	NDA216974
May 23, 2023	YUFLYMA	adalimumab-aaty	CELLTRION	BLA761219
May 22, 2023	OPVEE	nalmefene hydrochloride	INDIVIOR	NDA217470
May 22, 2023	PEMETREXED	pemetrexed disodium	SHILPA	NDA215179
May 19, 2023	EPKINLY	epcoritamab-bysp	GENMAB US, INC.	BLA761324
May 18, 2023	MIEBO	perfluorohexyloctane	BAUSCH AND LOMB INC	NDA216675
May 12, 2023	VEOZAH	fezolinetant	ASTELLAS	NDA216578
May 11, 2023	PACLITAXEL	paclitaxel	TEVA PHARMS INC	NDA216338
May 9, 2023	ELFABRIO	pegunigalsidase alfa-iwxj	CHIESI FARMACEUTICI SPA	BLA761161
May 9, 2023	ZOLPIDEM TARTRATE	zolpidem tartrate	ALMATICA	NDA215721
May 8, 2023	CEFAZOLIN SODIUM	cefazolin sodium	HQ SPCLT PHARMA	NDA211413
May 5, 2023	MYDCOMBI	phenylephrine hydrochloride, tropicamide	EYENOVIA	NDA215352
May 4, 2023	MOTPOLY XR	lacosamide	AUCTA	NDA216185
May 1, 2023	LUMRYZ	sodium oxybate	AVADEL CNS	NDA214755
April 28, 2023	LIQREV	sildenafil citrate	CMP DEV LLC	NDA214952
April 28, 2023	SYMBICORT AEROSPHERE	budesonide, formoterol fumarate	ASTRAZENECA	NDA216579
April 28, 2023	UZEDY	risperidone	TEVA	NDA213586
April 27, 2023	ABILIFY ASIMTUFII	aripiprazole	OTSUKA	NDA217006
April 26, 2023	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor, ivacaftor	VERTEX PHARMS INC	NDA217660
April 26, 2023	ZEJULA	niraparib tosylate	GLAXOSMITHKLINE	NDA214876
April 25, 2023	QALSODY	tofersen	BIOGEN MA	NDA215887
April 21, 2023	ADRENALIN	epinephrine	PH HEALTH	NDA215875
April 14, 2023	RIZAFILM	rizatriptan benzoate	GENSCO	NDA205394
March 24, 2023	JOENJA	leniolisib phosphate	PHARMING	NDA217759
March 22, 2023	REZZAYO	rezafungin acetate	MUNDIPHARMA	NDA217417
March 22, 2023	ZYNYZ	retifanlimab-dlwr	INCYTE CORP	BLA761334
March 16, 2023	MEKINIST	trametinib, trametinib dimethyl sulfoxide	NOVARTIS	NDA217513
March 16, 2023	TAFINLAR	dabrafenib mesylate	NOVARTIS	NDA217514
March 10, 2023	DAYBUE	trofinetide	ACADIA PHARMS INC	NDA217026
March 9, 2023	ZAVZPRET	zavegepant hydrochloride	PFIZER	NDA216386
March 7, 2023	REXTOVY	naloxone hydrochloride	AMPHASTAR PHARMS INC	NDA208969
March 1, 2023	COMBOGESIC	acetaminophen, ibuprofen	AFT PHARMS US	NDA209471
February 28, 2023	SKYCLARYS	omaveloxolone	BIOGEN US	NDA216718
February 23, 2023	PREVDUO	glycopyrrolate, neostigmine methylsulfate	AZURITY	NDA216903
February 17, 2023	AUSTEDO XR	deutetrabenazine	TEVA	NDA216354
February 17, 2023	FILSPARI	sparsentan	TRAVERE	NDA216403
February 17, 2023	SYFOVRE	pegcetacoplan	APELLIS PHARMS	NDA217171
February 16, 2023	LAMZEDE	velmanase alfa-tycv	CHIESI FARMACEUTICI SPA	BLA761278
February 8, 2023	FENTANYL CITRATE	fentanyl citrate	EXELA PHARMA	NDA215870
February 1, 2023	ATORVALIQ	atorvastatin calcium	CMP DEV LLC	NDA213260
February 1, 2023	JESDUVROQ	daprodustat	GLAXOSMITHKLINE	NDA216951
January 30, 2023	DAPTOMYCIN	daptomycin	HIKMA	NDA217415
January 30, 2023	TECHNETIUM TC 99M MERTIATIDE KIT	technetium tc-99m mertiatide kit	JUBILANT DRAXIMAGE	NDA216820
January 27, 2023	JAYPIRCA	pirtobrutinib	LOXO ONCOL	NDA216059
January 27, 2023	ORSERDU	elacestrant hydrochloride	STEMLINE THERAP	NDA217639
January 20, 2023	BRENZAVVY	bexagliflozin	THERACOSBIO	NDA214373
January 20, 2023	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	ZHEJIANG NOVUS PHARM	NDA210274
January 13, 2023	RYKINDO	risperidone	SHANDONG LUYE	NDA212849
January 10, 2023	AIRSUPRA	albuterol sulfate, budesonide	ASTRAZENECA	NDA214070
January 6, 2023	LEQEMBI	lecanemab-irmb	EISAI INC	BLA761269