All FDA drug approvals
FDA data · free, no account
FDA drug approvals in 2016
FDA approved the original submission of 100 new drug and biologics license applications in 2016, from 79 sponsors. FDA marks 21 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.
| Approved | Brand | Ingredient | Sponsor | Application |
|---|---|---|---|---|
| CASPOFUNGIN ACETATE | caspofungin acetate | FRESENIUS KABI USA | NDA206110 | |
| COLPREP KIT | magnesium sulfate, potassium sulfate, sodium sulfate | GATOR PHARMS | NDA204553 | |
| MEDICAL AIR, USP | medical air | GENERAL SERVICES & SUPPLY CO | NDA209927 | |
| SPINRAZA | nusinersen sodium | BIOGEN | NDA209531 | |
| RUBRACA | rucaparib camsylate | PHARMAAND | NDA209115 | |
| TIROSINT-SOL | levothyroxine sodium | IBSA | NDA206977 | |
| EUCRISA | crisaborole | ANACOR PHARMS INC | NDA207695 | |
| SYNJARDY XR | empagliflozin, metformin hydrochloride | BOEHRINGER INGELHEIM | NDA208658 | |
| ISOPTO ATROPINE | atropine sulfate | ALCON LABS INC | NDA208151 | |
| TIGECYCLINE | tigecycline | FRESENIUS KABI USA | NDA205645 | |
| SOLIQUA 100/33 | insulin glargine, lixisenatide | SANOFI-AVENTIS US | BLA208673 | |
| XULTOPHY 100/3.6 | insulin degludec, liraglutide | NOVO | BLA208583 | |
| INTRAROSA | prasterone | MILLICENT | NDA208470 | |
| VEMLIDY | tenofovir alafenamide fumarate | GILEAD SCIENCES INC | NDA208464 | |
| BONJESTA | doxylamine succinate, pyridoxine hydrochloride | DUCHESNAY | NDA209661 | |
| SELZENTRY | maraviroc | VIIV HLTHCARE | NDA208984 | |
| ZINPLAVA | bezlotoxumab | MERCK SHARP DOHME | BLA761046 | |
| EVZIO (AUTOINJECTOR) | naloxone hydrochloride | KALEO INC | NDA209862 | |
| LARTRUVO | olaratumab | ELI LILLY AND CO | BLA761038 | |
| VERMOX | mebendazole | JANSSEN PHARMS | NDA208398 | |
| TECENTRIQ | atezolizumab | GENENTECH INC | BLA761041 | |
| VARIBAR PUDDING | barium sulfate | BRACCO | NDA208844 | |
| CARNEXIV | carbamazepine | LUNDBECK PHARMS LLC | NDA206030 | |
| RUBY-FILL | rubidium chloride rb-82 | JUBILANT | NDA202153 | |
| LEVOLEUCOVORIN CALCIUM | levoleucovorin calcium | ACTAVIS LLC | NDA208723 | |
| AMJEVITA | adalimumab-atto | AMGEN INC | BLA761024 | |
| STELARA | ustekinumab | JANSSEN BIOTECH | BLA761044 | |
| EPANED | enalapril maleate | AZURITY | NDA208686 | |
| INVOKAMET XR | canagliflozin, metformin hydrochloride | JANSSEN PHARMS | NDA205879 | |
| EXONDYS 51 | eteplirsen | SAREPTA THERAPS INC | NDA206488 | |
| KYLEENA | levonorgestrel | BAYER HLTHCARE | NDA208224 | |
| YOSPRALA | aspirin, omeprazole | GENUS LIFESCIENCES | NDA205103 | |
| ERELZI | etanercept-szzs | SANDOZ | BLA761042 | |
| PALONOSETRON HYDROCHLORIDE | palonosetron hydrochloride | HIKMA | NDA207963 | |
| TROXYCA ER | naltrexone hydrochloride, oxycodone hydrochloride | PFIZER | NDA207621 | |
| SUSTOL | granisetron | HERON THERAPS INC | NDA022445 | |
| QBRELIS | lisinopril | AZURITY | NDA208401 | |
| ADLYXIN | lixisenatide | SANOFI-AVENTIS US | BLA208471 | |
| VIEKIRA XR | dasabuvir sodium, ombitasvir, paritaprevir, ritonavir | ABBVIE | NDA208624 | |
| RELISTOR | methylnaltrexone bromide | SALIX | NDA208271 | |
| SMOFLIPID 20% | fish oil, medium chain triglycerides, olive oil, soybean oil | FRESENIUS KABI USA | NDA207648 | |
| XIIDRA | lifitegrast | BAUSCH AND LOMB INC | NDA208073 | |
| SYNDROS | dronabinol | WELLHOUSE PHARMA | NDA205525 | |
| KOVANAZE | oxymetazoline hydrochloride, tetracaine hydrochloride | ST RENATUS | NDA208032 | |
| EPCLUSA | sofosbuvir, velpatasvir | GILEAD SCIENCES INC | NDA208341 | |
| RAYALDEE | calcifediol | EIRGEN | NDA208010 | |
| GONITRO | nitroglycerin | POHL BOSKAMP | NDA208424 | |
| LANSOPRAZOLE | lansoprazole | DEXCEL | NDA208025 | |
| BYVALSON | nebivolol hydrochloride, valsartan | ABBVIE | NDA206302 | |
| NETSPOT | gallium dotatate ga-68 | NOVARTIS | NDA208547 | |
| AXUMIN | fluciclovine f-18 | BLUE EARTH | NDA208054 | |
| JENTADUETO XR | linagliptin, metformin hydrochloride | BOEHRINGER INGELHEIM | NDA208026 | |
| OCALIVA | obeticholic acid | INTERCEPT | NDA207999 | |
| ZINBRYTA | daclizumab | BIOGEN | BLA761029 | |
| PROBUPHINE | buprenorphine hydrochloride | REACX PHARMS | NDA204442 | |
| TECENTRIQ | atezolizumab | GENENTECH INC | BLA761034 | |
| AMELUZ | aminolevulinic acid hydrochloride | BIOFRONTERA | NDA208081 | |
| AKOVAZ | ephedrine sulfate | EXELA PHARMA | NDA208289 | |
| AZACITIDINE | azacitidine | ACTAVIS LLC | NDA208216 | |
| FYCOMPA | perampanel | CATALYST PHARMS | NDA208277 | |
| NUPLAZID | pimavanserin tartrate | ACADIA PHARMS INC | NDA207318 | |
| OTOVEL | ciprofloxacin hydrochloride, fluocinolone acetonide | LAB SALVAT | NDA208251 | |
| ACTICLATE CAP | doxycycline hyclate | CHARTWELL RX | NDA208253 | |
| XTAMPZA ER | oxycodone | COLLEGIUM PHARM INC | NDA208090 | |
| BEVESPI AEROSPHERE | formoterol fumarate, glycopyrrolate | ASTRAZENECA | NDA208294 | |
| CABOMETYX | cabozantinib s-malate | EXELIXIS INC | NDA208692 | |
| TRIFERIC | ferric pyrophosphate citrate | ROCKWELL MEDICAL INC | NDA208551 | |
| ORFADIN | nitisinone | SWEDISH ORPHAN | NDA206356 | |
| FLOLIPID | simvastatin | SALERNO PHARMS | NDA206679 | |
| PHOTREXA VISCOUS IN DEXTRAN 20% | riboflavin 5'-phosphate, riboflavin 5'-phosphate sodium | GLAUKOS | NDA203324 | |
| VENCLEXTA | venetoclax | ABBVIE | NDA208573 | |
| BROMSITE | bromfenac sodium | SUN PHARM | NDA206911 | |
| PROVAYBLUE | methylene blue | PROVEPHARM SAS | NDA204630 | |
| ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | esmolol hydrochloride | HQ SPCLT PHARMA | NDA205703 | |
| INFLECTRA | infliximab-dyyb | CELLTRION INC | BLA125544 | |
| DESCOVY | emtricitabine, tenofovir alafenamide fumarate | GILEAD SCIENCES INC | NDA208215 | |
| DEFITELIO | defibrotide sodium | JAZZ PHARMS INC | NDA208114 | |
| CINQAIR | reslizumab | TEVA RESPIRATORY LLC | BLA761033 | |
| TALTZ | ixekizumab | ELI LILLY AND CO | BLA125521 | |
| ANTHIM | obiltoxaximab | ELUSYS THERAPEUTICS INC | BLA125509 | |
| EVOMELA | melphalan hydrochloride | ACROTECH BIOPHARMA | NDA207155 | |
| ODEFSEY | emtricitabine, rilpivirine hydrochloride, tenofovir alafenamide fumarate | GILEAD SCIENCES INC | NDA208351 | |
| POSFREA | palonosetron hydrochloride | AVYXA HOLDINGS | NDA203050 | |
| TETRACAINE HYDROCHLORIDE | tetracaine hydrochloride | ALCON LABS | NDA208135 | |
| ACZONE | dapsone | ALMIRALL | NDA207154 | |
| XELJANZ XR | tofacitinib citrate | PFIZER | NDA208246 | |
| HELIUM, USP | helium | NEXAIR LLC | NDA209033 | |
| BRIVIACT | brivaracetam | UCB INC | NDA205836 | |
| BRIVIACT | brivaracetam | UCB INC | NDA205837 | |
| BRIVIACT | brivaracetam | UCB INC | NDA205838 | |
| SERNIVO | betamethasone dipropionate | PRIMUS PHARMS | NDA208079 | |
| PARICALCITOL | paricalcitol | ACCORD HLTHCARE | NDA207174 | |
| CETYLEV | acetylcysteine | ARBOR PHARMS LLC | NDA207916 | |
| ZEMBRACE SYMTOUCH | sumatriptan succinate | TONIX MEDS | NDA208223 | |
| ZEPATIER | elbasvir, grazoprevir | MSD SUB MERCK | NDA208261 | |
| ADZENYS XR-ODT | amphetamine | NEOS THERAPS | NDA204326 | |
| ONZETRA XSAIL | sumatriptan succinate | AZURITY | NDA206099 | |
| DEXILANT SOLUTAB | dexlansoprazole | TAKEDA PHARMS USA | NDA208056 | |
| VARIBAR HONEY | barium sulfate | BRACCO | NDA208143 | |
| E-Z-CAT DRY | barium sulfate | BRACCO | NDA208036 |