All FDA drug approvals
FDA data · free, no account
FDA drug approvals in 2022
FDA approved the original submission of 123 new drug and biologics license applications in 2022, from 97 sponsors. FDA marks 14 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.
| Approved | Brand | Ingredient | Sponsor | Application |
|---|---|---|---|---|
| BRIUMVI | ublituximab-xiiy | TG THERAPEUTICS, INC | BLA761238 | |
| NEXOBRID | anacaulase-bcdb | MEDIWOUND, LTD | BLA761192 | |
| XENOVIEW | xenon xe-129 hyperpolarized | POLAREAN | NDA214375 | |
| LUNSUMIO VELO | mosunetuzumab-axgb | GENENTECH INC | BLA761263 | |
| OLPRUVA | sodium phenylbutyrate | ACER | NDA214860 | |
| SUNLENCA | lenacapavir sodium | GILEAD SCIENCES INC | NDA215973 | |
| SUNLENCA | lenacapavir sodium | GILEAD SCIENCES INC | NDA215974 | |
| BENDAMUSTINE HYDROCHLORIDE | bendamustine hydrochloride | HOSPIRA | NDA211530 | |
| BENDAMUSTINE HYDROCHLORIDE | bendamustine hydrochloride | BAXTER HLTHCARE CORP | NDA216078 | |
| IDACIO | adalimumab-aacf | FRESENIUS KABI USA | BLA761255 | |
| IYUZEH | latanoprost | THEA PHARMA | NDA216472 | |
| KRAZATI | adagrasib | BRISTOL | NDA216340 | |
| BENDAMUSTINE HYDROCHLORIDE | bendamustine hydrochloride | APOTEX | NDA215033 | |
| VIVIMUSTA | bendamustine hydrochloride | AZURITY | NDA212209 | |
| REZLIDHIA | olutasidenib | RIGEL PHARMS | NDA215814 | |
| JYLAMVO | methotrexate | SHORLA | NDA212479 | |
| DOCETAXEL | docetaxel | AVYXA HOLDINGS | NDA215813 | |
| SINCALIDE | sincalide | MAIA PHARMS INC | NDA210850 | |
| SEZABY | phenobarbital sodium | SUN PHARM INDS INC | NDA215910 | |
| TZIELD | teplizumab-mzwv | PROVENTION BIO INC | BLA761183 | |
| ELAHERE | mirvetuximab soravtansine-gynx | IMMUNOGEN INC | BLA761310 | |
| IMJUDO | tremelimumab-actl | ASTRAZENECA AB | BLA761270 | |
| TECVAYLI | teclistamab-cqyv | JANSSEN BIOTECH | BLA761291 | |
| IMJUDO | tremelimumab-actl | ASTRAZENECA AB | BLA761289 | |
| CEFAZOLIN SODIUM | cefazolin sodium | HIKMA | NDA216109 | |
| FUROSCIX | furosemide | SCPHARMACEUTICALS | NDA209988 | |
| NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | norepinephrine bitartrate | LONG GROVE PHARMS | NDA214628 | |
| LYTGOBI | futibatinib | TAIHO ONCOLOGY | NDA214801 | |
| RELYVRIO | sodium phenylbutyrate, taurursodiol | AMYLYX | NDA216660 | |
| IHEEZO | chloroprocaine hydrochloride | HARROW EYE | NDA216227 | |
| VEGZELMA | bevacizumab-adcd | CELLTRION | BLA761268 | |
| OMLONTI | omidenepag isopropyl | OCUVEX THERAP | NDA215092 | |
| ELUCIREM | gadopiclenol | GUERBET | NDA216986 | |
| PEDMARK | sodium thiosulfate | FENNEC PHARMS INC | NDA212937 | |
| APONVIE | aprepitant | HERON THERAPS INC | NDA216457 | |
| NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | norepinephrine bitartrate | INFORLIFE | NDA215700 | |
| TERLIVAZ | terlipressin acetate | MALLINCKRODT IRELAND | NDA022231 | |
| ROLVEDON | eflapegrastim-xnst | SPECTRUM PHARMS | BLA761148 | |
| SOTYKTU | deucravacitinib | BRISTOL | NDA214958 | |
| DAXXIFY | daxibotulinumtoxina-lanm | REVANCE THERAPEUTICS, INC. | BLA761127 | |
| SPEVIGO | spesolimab-sbzo | BOEHRINGER INGELHEIM PHARMACEUTICALS INC | BLA761244 | |
| STIMUFEND | pegfilgrastim-fpgk | FRESENIUS KABI USA | BLA761173 | |
| XENPOZYME | olipudase alfa-rpcp | GENZYME CORP | BLA761261 | |
| KONVOMEP | omeprazole, sodium bicarbonate | AZURITY | NDA213593 | |
| IMBRUVICA | ibrutinib | PHARMACYCLICS LLC | NDA217003 | |
| AUVELITY | bupropion hydrochloride, dextromethorphan hydrobromide | AXSOME | NDA215430 | |
| EPINEPHRINE | epinephrine | INTL MEDICATION SYS | NDA211363 | |
| MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR) | midazolam hydrochloride | RAFA LABS LTD | NDA216359 | |
| CALQUENCE | acalabrutinib maleate | ASTRAZENECA | NDA216387 | |
| CIMERLI | ranibizumab-eqrn | SANDOZ INC | BLA761165 | |
| ZORYVE | roflumilast | ARCUTIS | NDA215985 | |
| BORTEZOMIB | bortezomib | MAIA PHARMS INC | NDA215331 | |
| KYZATREX | testosterone undecanoate | MARIUS | NDA213953 | |
| PACLITAXEL | paclitaxel | AM REGENT | NDA211875 | |
| BORTEZOMIB | bortezomib | ACCORD HLTHCARE | NDA215441 | |
| MIDAZOLAM IN 0.8% SODIUM CHLORIDE | midazolam | EXELA PHARMA | NDA215868 | |
| PEMETREXED DISODIUM | pemetrexed disodium | ACCORD HLTHCARE | NDA214408 | |
| ZONISADE | zonisamide | AZURITY | NDA214273 | |
| BLUDIGO | indigotindisulfonate sodium | PROVEPHARM SAS | NDA216264 | |
| DROSPIRENONE | drospirenone | EXELTIS USA INC | NDA216285 | |
| VENLAFAXINE BESYLATE | venlafaxine besylate | ALMATICA | NDA215429 | |
| RELEXXII | methylphenidate hydrochloride | OSMOTICA PHARM US | NDA216117 | |
| PEMETREXED DISODIUM | pemetrexed disodium | HOSPIRA | NDA214218 | |
| PHEBURANE | sodium phenylbutyrate | MEDUNIK | NDA216513 | |
| TADLIQ | tadalafil | CMP DEV LLC | NDA214522 | |
| SKYRIZI | risankizumab-rzaa | ABBVIE INC | BLA761262 | |
| AMVUTTRA | vutrisiran sodium | ALNYLAM PHARMS INC | NDA215515 | |
| Nitrogen, NF | nitrogen | ABSOLUTE AIR, LLC | NDA217499 | |
| OXYGEN, USP | oxygen | ABSOLUTE AIR, LLC | NDA217500 | |
| PEMETREXED DITROMETHAMINE | pemetrexed ditromethamine | HOSPIRA | NDA208746 | |
| ACETAMINOPHEN | acetaminophen | HIKMA | NDA206968 | |
| AZMIRO | testosterone cypionate | AZURITY | NDA216318 | |
| FYLNETRA | pegfilgrastim-pbbk | KASHIV BIOSCIENCES LLC | BLA761084 | |
| PEMETREXED DISODIUM | pemetrexed disodium | SANDOZ | NDA214657 | |
| TYVASO DPI | treprostinil | UNITED THERAP | NDA214324 | |
| VTAMA | tapinarof | ORGANON LLC | NDA215272 | |
| TPOXX | tecovirimat | SIGA TECHNOLOGIES | NDA214518 | |
| CARMUSTINE | carmustine | ACCORD HLTHCARE | NDA215000 | |
| MOUNJARO | tirzepatide | ELI LILLY AND CO | NDA215866 | |
| RADICAVA ORS | edaravone | SHIONOGI | NDA215446 | |
| VOQUEZNA DUAL PAK | amoxicillin, vonoprazan fumarate | PHATHOM | NDA215153 | |
| VOQUEZNA TRIPLE PAK | amoxicillin, clarithromycin, vonoprazan fumarate | PHATHOM | NDA215152 | |
| BORTEZOMIB | bortezomib | HOSPIRA | NDA209191 | |
| ERMEZA | levothyroxine sodium | MYLAN | NDA215809 | |
| CAMZYOS | mavacamten | BRISTOL | NDA214998 | |
| CUVRIOR | trientine tetrahydrochloride | ORPHALAN | NDA215760 | |
| CARBON DIOXIDE, USP | carbon dioxide | LINDE GAS EQUIP | NDA217332 | |
| VIVJOA | oteseconazole | MYCOVIA PHARMS | NDA215888 | |
| EPSOLAY | benzoyl peroxide | MAYNE PHARMA | NDA214510 | |
| GLYCOPYRROLATE | glycopyrrolate | FRESENIUS KABI USA | NDA214919 | |
| ALYMSYS | bevacizumab-maly | AMNEAL PHARMS LLC | BLA761231 | |
| IGALMI | dexmedetomidine hydrochloride | BIOXCEL | NDA215390 | |
| VIJOICE | alpelisib | NOVARTIS | NDA215039 | |
| TRIUMEQ PD | abacavir sulfate, dolutegravir sodium, lamivudine | VIIV HLTHCARE | NDA215413 | |
| TLANDO | testosterone undecanoate | VERITY | NDA208088 | |
| LOCAMETZ | gallium ga-68 gozetotide | NOVARTIS | NDA215841 | |
| PLUVICTO | lutetium lu-177 vipivotide tetraxetan | NOVARTIS | NDA215833 | |
| HYFTOR | sirolimus | NOBELPHARMA | NDA213478 | |
| XELSTRYM | dextroamphetamine | NOVEN PHARMS INC | NDA215401 | |
| OPDUALAG | nivolumab, relatlimab-rmbw | BRISTOL MYERS SQUIBB | BLA761234 | |
| ZTALMY | ganaxolone | IMMEDICA PHARMA | NDA215904 | |
| NASONEX 24HR ALLERGY | mometasone furoate | PERRIGO PHARMA INTL | NDA215712 | |
| ATROPINE SULFATE | atropine sulfate | BAUSCH AND LOMB INC | NDA213581 | |
| ADLARITY | donepezil hydrochloride | CORIUM | NDA212304 | |
| ASPRUZYO SPRINKLE | ranolazine | SPIL | NDA216018 | |
| NALOXONE HYDROCHLORIDE (AUTOINJECTOR) | naloxone hydrochloride | KALEO INC | NDA215457 | |
| VONJO | pacritinib citrate | SOBI | NDA208712 | |
| ACUVUE THERAVISION WITH KETOTIFEN | ketotifen fumarate | JOHNSON JOHNSON VISN | NDA022388 | |
| CARBON DIOXIDE, USP | carbon dioxide | CONTINENTAL CARBONIC PRODUCTS, INC. | NDA217082 | |
| RELEUKO | filgrastim-ayow | KASHIV BIOSCIENCES LLC | BLA761082 | |
| NORLIQVA | amlodipine besylate | CMP DEV LLC | NDA214439 | |
| NEPHROSCAN | technetium tc-99m succimer | THERAGNOSTICS | NDA214993 | |
| PYRUKYND | mitapivat sulfate | AGIOS PHARMS INC | NDA216196 | |
| ENJAYMO | sutimlimab-jome | RECORDATI RARE DISEASES, INC. | BLA761164 | |
| FLEQSUVY | baclofen | AZURITY | NDA215602 | |
| CITALOPRAM HYDROBROMIDE | citalopram hydrobromide | ALMATICA | NDA215428 | |
| VABYSMO | faricimab-svoa | GENENTECH INC | BLA761235 | |
| DAPTOMYCIN IN 0.9% SODIUM CHLORIDE | daptomycin | BAXTER HLTHCARE CORP | NDA213645 | |
| KIMMTRAK | tebentafusp-tebn | IMMUNOCORE LTD | BLA761228 | |
| CIBINQO | abrocitinib | PFIZER | NDA213871 | |
| SOVUNA | hydroxychloroquine sulfate | NOVITIUM PHARMA | NDA214581 | |
| RYALTRIS | mometasone furoate, olopatadine hydrochloride | GLENMARK SPECLT | NDA211746 | |
| QUVIVIQ | daridorexant hydrochloride | IDORSIA | NDA214985 |