All FDA drug approvals
FDA data · free, no account
FDA drug approvals in 2021
FDA approved the original submission of 119 new drug and biologics license applications in 2021, from 103 sponsors. FDA marks 19 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.
| Approved | Brand | Ingredient | Sponsor | Application |
|---|---|---|---|---|
| RECORLEV | levoketoconazole | STRONGBRIDGE | NDA214133 | |
| CABAZITAXEL | cabazitaxel | ACCORD HLTHCARE | NDA207949 | |
| ADBRY | tralokinumab | LEO PHARMA AS | BLA761180 | |
| TASCENSO ODT | fingolimod lauryl sulfate | CYCLE | NDA214962 | |
| LEQVIO | inclisiran sodium | NOVARTIS | NDA214012 | |
| APRETUDE | cabotegravir | VIIV HLTHCARE | NDA215499 | |
| XARELTO | rivaroxaban | JANSSEN PHARMS | NDA215859 | |
| ILLUCCIX | gallium ga-68 gozetotide | TELIX | NDA214032 | |
| LANREOTIDE ACETATE | lanreotide acetate | INVAGEN PHARMS | NDA215395 | |
| OXBRYTA | voxelotor | GLOBAL BLOOD THERAPS | NDA216157 | |
| REZVOGLAR | insulin glargine-aglr | ELI LILLY CO | BLA761215 | |
| TEZSPIRE | tezepelumab-ekko | ASTRAZENECA AB | BLA761224 | |
| VYVGART | efgartigimod alfa | ARGENX BV | BLA761195 | |
| YUSIMRY | adalimumab-aqvh | EMERGE BIOSCIENCE PTE. LTD. | BLA761216 | |
| DARTISLA ODT | glycopyrrolate | EDENBRIDGE PHARMS | NDA215019 | |
| TARPEYO | budesonide | CALLIDITAS | NDA215935 | |
| ENTADFI | finasteride, tadalafil | BLUE WATER BIOTECH | NDA215423 | |
| XACIATO | clindamycin phosphate | ORGANON LLC | NDA215650 | |
| CYTALUX | pafolacianine sodium | ON TARGET LABS | NDA214907 | |
| LIVTENCITY | maribavir | TAKEDA PHARMS USA | NDA215596 | |
| FYARRO | sirolimus | AADI | NDA213312 | |
| LYVISPAH | baclofen | STRIDES PHARMA INTL | NDA215422 | |
| VOXZOGO | vosoritide | BIOMARIN PHARM | NDA214938 | |
| BESREMI | ropeginterferon alfa-2b-njft | PHARMAESSENTIA CORP | BLA761166 | |
| DHIVY | carbidopa, levodopa | AVION PHARMS | NDA214869 | |
| EPRONTIA | topiramate | AZURITY | NDA214679 | |
| DYANAVEL XR 20 | amphetamine, amphetamine aspartate/dextroamphetamine sulfate | TRIS PHARMA INC | NDA210526 | |
| SCEMBLIX | asciminib hydrochloride | NOVARTIS | NDA215358 | |
| DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% | diltiazem hydrochloride | EXELA PHARMA | NDA215252 | |
| VUITY | pilocarpine hydrochloride | ABBVIE | NDA214028 | |
| SUSVIMO | ranibizumab | GENENTECH INC | BLA761197 | |
| XIPERE | triamcinolone acetonide | BAUSCH AND LOMB INC | NDA211950 | |
| CARBON DIOXIDE, USP | carbon dioxide | MIDDLESEX GASES TECHNOLOGIES, INC. | NDA216614 | |
| SEGLENTIS | celecoxib, tramadol hydrochloride | KOWA PHARMS | NDA213426 | |
| TYRVAYA | varenicline tartrate | OYSTER POINT PHARMA | NDA213978 | |
| ZIMHI | naloxone hydrochloride | ZMI PHARMA | NDA212854 | |
| TAVNEOS | avacopan | CHEMOCENTRYX | NDA214487 | |
| SERTRALINE HYDROCHLORIDE | sertraline hydrochloride | ALMATICA | NDA215133 | |
| LIVMARLI | maralixibat chloride | MIRUM | NDA214662 | |
| QULIPTA | atogepant | ABBVIE | NDA215206 | |
| OPZELURA | ruxolitinib phosphate | INCYTE CORP | NDA215309 | |
| TIVDAK | tisotumab vedotin-tftv | SEAGEN | BLA761208 | |
| BYOOVIZ | ranibizumab-nuna | SAMSUNG BIOEPIS CO LTD | BLA761202 | |
| EXKIVITY | mobocertinib succinate | TAKEDA PHARMS USA | NDA215310 | |
| TRUDHESA | dihydroergotamine mesylate | IMPEL PHARMS | NDA213436 | |
| LOREEV XR | lorazepam | ALMATICA | NDA214826 | |
| VANCOMYCIN | vancomycin | HIKMA | NDA213895 | |
| CYCLOPHOSPHAMIDE | cyclophosphamide | EUGIA PHARMA SPECLTS | NDA210735 | |
| SKYTROFA | lonapegsomatropin-tcgd | ASCENDIS PHARMA ENCOCRINOLOGY DIV A/S | BLA761177 | |
| KORSUVA | difelikefalin acetate | VIFOR INTL | NDA214916 | |
| SUCCINYLCHOLINE CHLORIDE | succinylcholine chloride | HIKMA | NDA215143 | |
| JEMPERLI | dostarlimab-gxly | GLAXOSMITHKLINE LLC | BLA761223 | |
| WELIREG | belzutifan | MERCK SHARP DOHME | NDA215383 | |
| NEXVIAZYME | avalglucosidase alfa-ngpt | GENZYME CORP | BLA761194 | |
| MICAFUNGIN | micafungin sodium | TEVA PHARMS USA INC | NDA212125 | |
| SAPHNELO | anifrolumab-fnia | ASTRAZENECA AB | BLA761123 | |
| UPTRAVI | selexipag | ACTELION | NDA214275 | |
| SEMGLEE | insulin glargine-yfgn | MYLAN PHARMS INC | BLA761201 | |
| HELIUM, USP | helium | GENERAL AIR SERVICE & SUPPLY COMPANY | NDA216307 | |
| TWYNEO | benzoyl peroxide, tretinoin | MAYNE PHARMA | NDA214902 | |
| BYLVAY | odevixibat | IPSEN | NDA215498 | |
| FEXINIDAZOLE | fexinidazole | SANOFI | NDA214429 | |
| REZUROCK | belumosudil mesylate | KADMON PHARMS LLC | NDA214783 | |
| KERENDIA | finerenone | BAYER HLTHCARE | NDA215341 | |
| RYLAZE | asparaginase erwinia chrysanthemi (recombinant)-rywn | JAZZ PHARMS | BLA761179 | |
| VERKAZIA | cyclosporine | HARROW EYE | NDA214965 | |
| DAPTOMYCIN | daptomycin | HOSPIRA | NDA210282 | |
| PRADAXA | dabigatran etexilate mesylate | BOEHRINGER INGELHEIM | NDA214358 | |
| ASTEPRO ALLERGY | azelastine hydrochloride | BAYER HLTHCARE | NDA213872 | |
| MICAFUNGIN | micafungin sodium | PH HEALTH | NDA212156 | |
| REZIPRES | ephedrine hydrochloride | DR REDDYS LABS SA | NDA213536 | |
| SOAANZ | torsemide | SARFE PHARMS | NDA213218 | |
| EPCLUSA | sofosbuvir, velpatasvir | GILEAD SCIENCES INC | NDA214187 | |
| MAVYRET | glecaprevir, pibrentasvir | ABBVIE | NDA215110 | |
| SODIUM PHENYLACETATE AND SODIUM BENZOATE | sodium benzoate, sodium phenylacetate | MAIA PHARMS INC | NDA215025 | |
| ADUHELM | aducanumab-avwa | BIOGEN INC | BLA761178 | |
| ARGATROBAN IN SODIUM CHLORIDE | argatroban | ACCORD HLTHCARE | NDA212035 | |
| TEMBEXA | brincidofovir | EMERGENT BIODEFENSE | NDA214460 | |
| TEMBEXA | brincidofovir | EMERGENT BIODEFENSE | NDA214461 | |
| WEGOVY | semaglutide | NOVO | NDA215256 | |
| BREXAFEMME | ibrexafungerp citrate | GLAXOSMITHKLINE | NDA214900 | |
| NOXAFIL POWDERMIX KIT | posaconazole | MSD MERCK CO | NDA214770 | |
| LUMAKRAS | sotorasib | AMGEN INC | NDA214665 | |
| LYBALVI | olanzapine, samidorphan l-malate | ALKERMES INC | NDA213378 | |
| TRUSELTIQ | infigratinib phosphate | HELSINN HLTHCARE | NDA214622 | |
| MYFEMBREE | estradiol, norethindrone acetate, relugolix | SUMITOMO PHARMA AM | NDA214846 | |
| PYLARIFY | piflufolastat f-18 | PROGENICS PHARMS INC | NDA214793 | |
| CAMCEVI KIT | leuprolide mesylate | ACCORD | NDA211488 | |
| RYBREVANT | amivantamab-vmjw | JANSSEN BIOTECH | BLA761210 | |
| LEVOTHYROXINE SODIUM | levothyroxine sodium | HIKMA | NDA214253 | |
| EMPAVELI | pegcetacoplan | APELLIS PHARMS | NDA215014 | |
| ZYNRELEF KIT | bupivacaine, meloxicam | HERON THERAPS INC | NDA211988 | |
| KLOXXADO | naloxone hydrochloride | HIKMA | NDA212045 | |
| ZYNLONTA | loncastuximab tesirine-lpyl | ADC Therapeutics SA | BLA761196 | |
| JEMPERLI | dostarlimab-gxly | GLAXOSMITHKLINE | BLA761174 | |
| NEXTSTELLIS | drospirenone, estetrol | MAYNE PHARMA | NDA214154 | |
| QELBREE | viloxazine hydrochloride | SUPERNUS PHARMS | NDA211964 | |
| MYRBETRIQ GRANULES | mirabegron | APGDI | NDA213801 | |
| ROSZET | ezetimibe, rosuvastatin calcium | ALTHERA PHARMS | NDA213072 | |
| MIDAZOLAM IN 0.9% SODIUM CHLORIDE | midazolam | INFORLIFE | NDA211844 | |
| ZEGALOGUE | dasiglucagon hydrochloride | ZEALAND PHARMA | NDA214231 | |
| PONVORY | ponesimod | VANDA PHARMS INC | NDA213498 | |
| KIMYRSA | oritavancin diphosphate | MELINTA THERAP | NDA214155 | |
| FOTIVDA | tivozanib hydrochloride | AVEO PHARMS | NDA212904 | |
| AZSTARYS | dexmethylphenidate hydrochloride, serdexmethylphenidate chloride | COMMAVE SUB | NDA212994 | |
| NULIBRY | fosdenopterin hydrobromide | SENTYNL THERAPS INC | NDA214018 | |
| AMONDYS 45 | casimersen | SAREPTA THERAPS INC | NDA213026 | |
| ACETAMINOPHEN | acetaminophen | B BRAUN MEDICAL | NDA204957 | |
| COSELA | trilaciclib dihydrochloride | PHARMACOSMOS | NDA214200 | |
| EVKEEZA | evinacumab-dgnb | REGENERON PHARMACEUTICALS | BLA761181 | |
| UKONIQ | umbralisib tosylate | TG THERAPS | NDA213176 | |
| TEPMETKO | tepotinib hydrochloride | EMD SERONO INC | NDA214096 | |
| POSIMIR | bupivacaine | INNOCOLL | NDA204803 | |
| LUPKYNIS | voclosporin | AURINIA | NDA213716 | |
| CABENUVA KIT | cabotegravir, rilpivirine | VIIV HLTHCARE | NDA212888 | |
| VOCABRIA | cabotegravir sodium | VIIV HLTHCARE | NDA212887 | |
| VERQUVO | vericiguat | MSD | NDA214377 | |
| ACETAMINOPHEN | acetaminophen | RISING | NDA206610 | |
| NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | norepinephrine bitartrate | BAXTER HLTHCARE CORP | NDA214313 |