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FDA drug approvals in 2012

FDA approved the original submission of 87 new drug and biologics license applications in 2012, from 75 sponsors. FDA marks 20 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

Approved	Brand	Ingredient	Sponsor	Application
December 31, 2012	MYTESI	crofelemer	NAPO PHARMS INC	NDA202292
December 28, 2012	ELIQUIS	apixaban	BRISTOL MYERS SQUIBB	NDA202155
December 28, 2012	SIRTURO	bedaquiline fumarate	JANSSEN THERAP	NDA204384
December 21, 2012	ADASUVE	loxapine	NOVA PNEUMA	NDA022549
December 21, 2012	GATTEX KIT	teduglutide	TAKEDA PHARMS USA	NDA203441
December 21, 2012	JUXTAPID	lomitapide mesylate	CHIESI	NDA203858
December 20, 2012	IMMPHENTIV	phenylephrine hydrochloride	HIKMA	NDA203826
December 20, 2012	TOPOTECAN HYDROCHLORIDE	topotecan hydrochloride	MEITHEAL	NDA022453
December 14, 2012	ICLUSIG	ponatinib hydrochloride	TAKEDA PHARMS USA	NDA203469
December 14, 2012	LUPANETA PACK	leuprolide acetate, norethindrone acetate	ABBVIE ENDOCRINE	NDA203696
December 14, 2012	ONFI	clobazam	LUNDBECK PHARMS LLC	NDA203993
December 14, 2012	RAXIBACUMAB	raxibacumab	HUMAN GENOME SCIENCES INC.	BLA125349
December 14, 2012	SIGNIFOR	pasireotide diaspartate	RECORDATI RARE	NDA200677
December 7, 2012	ADRENALIN	epinephrine	PH HEALTH	NDA204200
November 29, 2012	COMETRIQ	cabozantinib s-malate	EXELIXIS	NDA203756
November 6, 2012	XELJANZ	tofacitinib citrate	PF PRISM CV	NDA203214
October 29, 2012	MINIVELLE	estradiol	NOVEN	NDA203752
October 26, 2012	SYNRIBO	omacetaxine mepesuccinate	TEVA PHARMS INTL	NDA203585
October 22, 2012	FYCOMPA	perampanel	CATALYST PHARMS	NDA202834
October 19, 2012	OXTELLAR XR	oxcarbazepine	SUPERNUS PHARMS	NDA202810
October 17, 2012	JETREA	ocriplasmin	THROMBOGENICS, INC	BLA125422
October 16, 2012	ILEVRO	nepafenac	HARROW EYE	NDA203491
October 15, 2012	NUCYNTA	tapentadol hydrochloride	COLLEGIUM PHARM INC	NDA203794
October 12, 2012	BETHKIS	tobramycin	CHIESI	NDA201820
October 2, 2012	CYSTARAN	cysteamine hydrochloride	LEADIANT BIOSCI INC	NDA200740
September 28, 2012	LOTEMAX	loteprednol etabonate	BAUSCH AND LOMB INC	NDA202872
September 27, 2012	QUILLIVANT XR	methylphenidate hydrochloride	NEXTWAVE	NDA202100
September 27, 2012	STIVARGA	regorafenib	BAYER HLTHCARE	NDA203085
September 12, 2012	AUBAGIO	teriflunomide	SANOFI AVENTIS US	NDA202992
September 12, 2012	CHOLINE C-11	choline c-11	MCPRF	NDA203155
September 4, 2012	BOSULIF	bosutinib monohydrate	PF PRISM CV	NDA203341
August 31, 2012	XTANDI	enzalutamide	ASTELLAS	NDA203415
August 30, 2012	LINZESS	linaclotide	ABBVIE	NDA202811
August 30, 2012	REVATIO	sildenafil citrate	VIATRIS	NDA203109
August 29, 2012	AFINITOR DISPERZ	everolimus	NOVARTIS PHARM	NDA203985
August 29, 2012	GRANIX	tbo-filgrastim	SICOR BIOTECH	BLA125294
August 27, 2012	STRIBILD	cobicistat, elvitegravir, emtricitabine, tenofovir disoproxil fumarate	GILEAD SCIENCES INC	NDA203100
August 10, 2012	AUVI-Q	epinephrine	KALEO INC	NDA201739
August 9, 2012	MARQIBO KIT	vincristine sulfate	ACROTECH	NDA202497
August 3, 2012	ZALTRAP	ziv-aflibercept	SANOFI AVENTIS US	BLA125418
July 26, 2012	RAYOS	prednisone	HORIZON	NDA202020
July 26, 2012	VASCEPA	icosapent ethyl	AMARIN PHARMS	NDA202057
July 23, 2012	TUDORZA PRESSAIR	aclidinium bromide	AZURITY	NDA202450
July 20, 2012	KYPROLIS	carfilzomib	ONYX PHARMS AMGEN	NDA202714
July 17, 2012	QSYMIA	phentermine hydrochloride, topiramate	VIVUS LLC	NDA022580
July 16, 2012	PREPOPIK	citric acid, magnesium oxide, sodium picosulfate	FERRING PHARMS INC	NDA202535
July 11, 2012	XIMINO	minocycline hydrochloride	JOURNEY	NDA201922
June 28, 2012	MYRBETRIQ	mirabegron	APGDI	NDA202611
June 12, 2012	ADVIL	ibuprofen sodium	HALEON US HOLDINGS	NDA201803
June 8, 2012	PERJETA	pertuzumab	GENENTECH	BLA125409
June 1, 2012	SUPRAX	cefixime	LUPIN LTD	NDA203195
May 25, 2012	ABSORICA	isotretinoin	SUN PHARM INDS INC	NDA021951
May 17, 2012	PERTZYE	pancrelipase (amylase, lipase, protease)	DIGESTIVE CARE INC	BLA022175
May 11, 2012	FABIOR	tazarotene	MAYNE PHARMA	NDA202428
May 1, 2012	DYMISTA	azelastine hydrochloride, fluticasone propionate	MYLAN SPECIALITY LP	NDA202236
May 1, 2012	ELELYSO	taliglucerase alfa	PFIZER	BLA022458
April 27, 2012	STENDRA	avanafil	VIVUS LLC	NDA202276
April 6, 2012	AMYVID	florbetapir f-18	AVID RADIOPHARMS INC	NDA202008
March 27, 2012	OMONTYS	peginesatide acetate	TAKEDA PHARMS USA	NDA202799
March 23, 2012	QNASL	beclomethasone dipropionate	TEVA BRANDED PHARM	NDA202813
March 12, 2012	BINOSTO	alendronate sodium	RADIUS	NDA202344
March 6, 2012	SURFAXIN	lucinactant	LEES PHARM HK	NDA021746
March 1, 2012	VIOKACE	pancrelipase (amylase, lipase, protease)	VIOKACE	BLA022542
February 17, 2012	KORLYM	mifepristone	CORCEPT THERAP	NDA202107
February 14, 2012	SODIUM NITRITE	sodium nitrite	HOPE PHARMS	NDA203922
February 14, 2012	SODIUM THIOSULFATE	sodium thiosulfate	HOPE PHARMS	NDA203923
February 14, 2012	TESTOSTERONE	testosterone	ANI PHARMS	NDA202763
February 10, 2012	ZIOPTAN	tafluprost	THEA PHARMA	NDA202514
February 7, 2012	MITOSOL	mitomycin	GLAUKOS	NDA022572
February 7, 2012	SKLICE	ivermectin	ARBOR PHARMS LLC	NDA202736
February 3, 2012	GIAZO	balsalazide disodium	VALEANT PHARMS INTL	NDA022205
February 2, 2012	JANUMET XR	metformin hydrochloride, sitagliptin phosphate	MSD SUB MERCK	NDA202270
February 1, 2012	COSOPT PF	dorzolamide hydrochloride, timolol maleate	THEA PHARMA	NDA202667
January 31, 2012	KALYDECO	ivacaftor	VERTEX PHARMS	NDA203188
January 30, 2012	ERIVEDGE	vismodegib	GENENTECH	NDA203388
January 30, 2012	JENTADUETO	linagliptin, metformin hydrochloride	BOEHRINGER INGELHEIM	NDA201281
January 27, 2012	BYDUREON PEN	exenatide synthetic	ASTRAZENECA AB	NDA022200
January 27, 2012	INLYTA	axitinib	PF PRISM CV	NDA202324
January 23, 2012	PICATO	ingenol mebutate	LEO LABS	NDA202833
January 20, 2012	ZETONNA	ciclesonide	AZURITY	NDA202129
January 18, 2012	VIREAD	tenofovir disoproxil fumarate	GILEAD SCIENCES INC	NDA022577
January 17, 2012	VORAXAZE	glucarpidase	BTG INTERNATIONAL INC	BLA125327
January 12, 2012	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	VISTAPHARM LLC	NDA201194
January 11, 2012	DOCETAXEL	docetaxel	APOTEX INC	NDA022312
January 6, 2012	SODIUM CHLORIDE 0.9%	sodium chloride	MEDEFIL INC	NDA202832
January 5, 2012	ARGATROBAN	argatroban	HIKMA PHARM CO LTD	NDA203049
January 4, 2012	SUBSYS	fentanyl	BTCP PHARMA	NDA202788