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THERAPY CLASSDRUG NAMEACTIVE INGREDIENTPRODUCT TYPEAPPROVAL DATEAPPLICANT
Inflammatory ConditionsInflectraInfliximab-dyybBiosimilar5-Apr-16Celltrion Inc
Inflammatory ConditionsErelziEtanercept-szzsBiosimilar30-Aug-16Sandoz
Inflammatory ConditionsAmjevitaAdalimumab-attoBiosimilar23-Sep-16Amgen Inc
Vaginal DisorderIntrarosaPrasteroneNew Active Ingredient16-Nov-16Endoceutics Inc
Health and NutritionSmoflipid 20%Fish Oil, Medium Chain Triglycerides, Olive Oil, Soybean OilNew Active Ingredient13-Jul-16Fresenius Kabi USA LLC
Diagnostic AgentE-Z-HDBarium SulfateNew Active Ingredient11-Jan-16Bracco Diagnostics Inc
Diagnostic AgentVaribarBarium SulfateNew Active Ingredient14-Oct-16Bracco Diagnostics Inc
Diagnostic AgentReadi-Cat 2Barium SulfateNew Active Ingredient15-Jan-16Bracco Diagnostics Inc
Blood DisorderProvayblueMethylene BlueNew Active Ingredient8-Apr-16Provepharm SAS
Heart DiseaseYospralaAspirin, OmeprazoleNew Combination14-Sep-16Aralez Pharmaceuticals
COPDBevespi AerosphereFormoterol Fumarate, GlycopyrrolateNew Combination25-Apr-16Pearl Theraps Inc
DiabetesOdefseyLinagliptin, Metformin HydrochlorideNew Combination27-May-16Boehringer Ingelheim
DiabetesInvokamet XRCanagliflozin, Metformin HydrochlorideNew Combination20-Sep-16Janssen Pharms
DiabetesSoliquaInsulin Glargine, LixisenatideNew Combination21-Nov-16Sanofi-Aventis US
DiabetesXultophyInsulin Degludec, LiraglutideNew Combination21-Nov-16Novo Nordisk Inc
Heart DiseaseByvalsonNebivolol Hydrochloride, ValsartanNew Combination3-Jun-16Forest Labs LLC
HIVOdefseyEmtricitabine, Rilpivirine Hydrochloride, Tenofovir Alafenamide FumarateNew Combination1-Mar-16Gilead Sciences Inc
HIVDescovyEmtricitabine, Tenofovir Alafenamide FumarateNew Combination4-Apr-16Gilead Sciences Inc
AntibacterialOtovelCiprofloxacin Hydrochloride, Fluocinolone AcetonideNew Combination29-Apr-16Laboratorios Salvat SA
Gastrointestinal DisorderRelistorMethylnaltrexone BromideNew Dosage Form19-Jul-16Salix Pharmaceuticals, Inc
DiabetesSynjardy XR Empagliflozin, Metformin HydrochlorideNew Dosage Form9-Dec-16Boehringer Ingelheim
Heart DiseaseGoNitroNitroglycerinNew Dosage Form8-Jun-16Pohl Boskamp
Gastrointestinal DisorderDexilant SoluTabDexlansoprazoleNew Dosage Form26-Jan-16Takeda Pharms USA
Hepatitis CViekira XRDasabuvir Sodium, Ombitasvir, Paritaprevir, RitonavirNew Dosage Form22-Jul-16Abbvie
Heart DiseaseQbrelisLisinoprilNew Dosage Form29-Jul-16Silvergate Pharms
HIVSelzentryMaravirocNew Dosage Form4-Nov-16ViiV Healthcare
Inflammatory ConditionsXeljanz XRTofacitinib CitrateNew Dosage Form23-Feb-16Pfizer Inc
MigraineOnzetra XsailSumatriptan SuccinateNew Dosage Form27-Jan-16Avanir Pharms
Nausea, VomitingSyndrosDronabinolNew Dosage Form1-Jul-16Insys Dev Co Inc
Nausea, VomitingSustolGranisetronNew Dosage Form9-Aug-16Heron Theraps Inc
OncologyCabometyxCabozantinib S-MalateNew Dosage Form25-Apr-16Exelixis Inc
Opioid DependenceProbuphineBuprenorphine HydrochlorideNew Dosage Form26-May-16Braeburn Pharms Inc
Mental/Neurological DisorderCarnexivCarbamazepineNew Dosage Form7-Oct-16Lundbeck LLC
Skin DisorderSernivoBetamethasone DipropionateNew Dosage Form5-Feb-16Promius Pharma LLC
Mental/Neurological DisorderAdzenys XR-ODTAmphetamineNew Dosage Form27-Jan-16Neos Therapeutics, Inc
Heart DiseaseAkovazEphedrine SulfateNew Dosage Form29-Apr-16Flamel Ireland Ltd
MigraineZembrace SymTouchSumatriptan SuccinateNew Dosage Form28-Jan-16Dr Reddys Labs Ltd
OncologyEvomelaMelphalan HydrochlorideNew Dosage Form10-Mar-16Spectrum Pharms
Vitamins and MineralsRayaldeeCalcifediolNew Dosage Form17-Jun-16Opko Ireland Global Holdings Ltd.
Weight LossBelviq XRLorcaserin HydrochlorideNew Dosage Form15-Jul-16Eisai Inc
Blood DisorderTrifericFerric Pyrophosphate CitrateNew Dosage Form25-Apr-16Rockwell Medical Inc
Skin DisorderAmeluzAminolevulinic Acid HydrochlorideNew Dosage Form10-May-16Biofrontera Bioscience Gmbh
Ophthalmic ConditionsPhotrexaRiboflavin 5'-Phosphate SodiumNew Dosage Form15-Apr-16Avedro Inc
Heart DiseaseEsmolol Hydrochloride In Plastic ContainerEsmolol HydrochlorideNew Dosage Form7-Apr-16HQ Specialty Pharma Corp
Diagnostic AgentRuby-FillRubidium Chloride Rb-82New Dosage Form30-Sep-16Jubilant Draximage Inc
Mental/Neurological DisorderFycompaPerampanelNew Dosage Form29-Apr-16Eisai Inc
Hepatic DisorderCetylevAcetylcysteineNew Dosage Form29-Jan-16Arbor Pharmaceuticals LLC
Orphan DiseaseOrfadinNitisinoneNew Dosage Form22-Apr-16Swedish Orphan Biovitrum Ab Publ
Opioid Pain ManagementTroxyca EROxycodone, NaltrexoneNew Dosage Form, New Combination1-Aug-19Pfizer Inc
AnesthesiaKovanazeOxymetazoline Hydrochloride, Tetracaine HydrochlorideNew Dosage Form, New Combination29-Jun-16St Renatus LLC
HemophiliaIdelvionCoagulation Factor IX (Recombinant), Albumin Fusion ProteinNew Formulation4-Mar-16CSL Behring
HemophiliaKovaltryAntihemophilic Factor [Recombinant]New Formulation16-Mar-16Bayer Healthcare, LLC
HemophiliaAfstylaAntihemophilic Factor [Recombinant], Single ChainNew Formulation25-May-16CSL Behring, LLC
Immune DeficiencyCuvitru[Immune Globulin Subcutaneous (Human)] 20%New Formulation13-Sep-16Baxalta US, Inc.
ContraceptivesKyleenaLevonorgestrel-Releasing Intrauterine SystemNew Strength16-Sep-16Bayer Healthcare
Nausea, VomitingBonjestaDoxylamine Succinate, Pyridoxine HydrochlorideNew Strength7-Nov-16Duchesnay
Ophthalmic ConditionsBromSiteBromfenac SodiumNew Strength8-Apr-16Sun Pharma Global
Opioid Pain ManagementXtampza EROxycodoneNew Strength26-Apr-16Collegium Pharm Inc
Hepatitis BVemlidyTenofovir Alafenamide FumarateNew Strength10-Nov-16Gilead Sciences Inc
Skin DisorderAczoneDapsoneNew Strength24-Feb-16Allergan Inc
Opioid DependenceEvzioNaloxone HydrochlorideNew Strength19-Oct-16Kaleo Inc
Infectious DiseasesVermoxMebendazoleNew Strength19-Oct-16Janssen Pharmaceuticals Inc
VaccinationsVaxchoraCholera VaccineNew Vaccine10-Jun-16Pax Vax Bermuda Ltd.
VaccinationsFlucelvax QuadrivalentInfluenza VaccineNew Vaccine Formulation24-May-16Seqirus, Inc.
VaccinationsAfluria QuadrivalentInfluenza VaccineNew Vaccine Formulation29-Aug-16Seqirus Pty. Ltd.
VaccinationsFlublok QuadrivalentInfluenza VaccineNew Vaccine Formulation11-Oct-16Protein Sciences Corporation
Orphan DiseaseDefitelioDefibrotide SodiumNovel Drug30-Mar-16Jazz Pharmaceuticals, Inc
Asthma CinqairReslizumabNovel Drug23-Mar-16Teva Pharmaceuticals
DiabetesAdlyxinLixisenatideNovel Drug27-Jul-16Sanofi-Aventis U.S. LLC
Orphan DiseaseOcalivaObeticholic AcidNovel Drug27-May-16Intercept Pharmaceuticals
Hepatitis CZepatierElbasvir, GrazoprevirNovel Drug28-Jan-16Merck & Co.
Hepatitis CEpclusaSofosbuvir, VelpatasvirNovel Drug28-Jun-16Gilead Sciences Inc
Mental/Neurological DisorderNuplazidPimavanserinNovel Drug29-Apr-16Acadia Pharms Inc
Orphan DiseaseExondys 51EteplirsenNovel Drug19-Sep-16Sarepta Theraps Inc
Multiple SclerosisZinbrytaDaclizumabNovel Drug27-May-16Biogen, Inc.
Orphan DiseaseSpinrazaNusinersenNovel Drug23-Dec-16Biogen Idec
OncologyVenclextaVenetoclaxNovel Drug11-Apr-16Abbvie Inc
OncologyTecentriqAtezolizumabNovel Drug18-May-16Genentech Inc
Orphan Oncology DiseaseLartruvoOlaratumabNovel Drug19-Oct-16Eli Lilly And Co
Orphan Oncology DiseaseRubracaRucaparibNovel Drug19-Dec-16Clovis Oncology Inc
Ophthalmic ConditionsXiidraLifitegrast Ophthalmic SolutionNovel Drug11-Jul-16Shire Dev Llc
Infectious DiseasesZinplavaBezlotoxumabNovel Drug21-Oct-16Merck Sharp Dohme
Mental/Neurological DisorderBriviactBrivaracetamNovel Drug18-Feb-16UCB Inc
Skin DisorderTaltzIxekizumabNovel Drug22-Mar-16Eli Lilly And Co
Skin DisorderEucrisaCrisaboroleNovel Drug14-Dec-16Anacor Pharms Inc
Orphan DiseaseAnthimObiltoxaximabNovel Drug18-Mar-16Elusys Therapeutics Inc
Diagnostic AgentAxuminFluciclovine F-18Novel Drug27-May-16Blue Earth
Diagnostic Agent [Orphan]NetspotGallium Dotatate Ga-68Novel Drug1-Jun-16AAA USA Inc