Alphabetical Listing of all New Drug Applications

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• 1UO (uracil)
  Treatment for: Hand-Foot Syndrome
• A-101 (hydrogen peroxide)
  Treatment for: Seborrheic Dermatitis
• abemaciclib
  Treatment for: Breast Cancer
• Abilify Digital (aripiprazole)
  Treatment for: Schizophrenia, Bipolar Disorder
• ABP 215 (bevacizumab)
  Treatment for: Non-Small Cell Lung Cancer, Colorectal Cancer, Glioblastoma Multiforme, Renal Cell Carcinoma, Breast Cancer, Ovarian Cancer
• ADL5859
  Treatment for: Pain
• ADS-5102 (amantadine hydrochloride)
  Treatment for: Parkinson's Disease
• aducanumab
  Treatment for: Alzheimer's Disease
• Advexin (p53 tumor suppressor therapy)
  Treatment for: Head and Neck Cancer
• Amphora
  Treatment for: Birth Control
• Ampligen (rintatolimod)
  Treatment for: Chronic Fatigue Syndrome
• AndexXa (andexanet alfa)
  Treatment for: Reversal of Anticoagulant Activity of Factor Xa Inhibitors
• Androxal (enclomiphene)
  Treatment for: Hypogonadism, Male
• Apadaz (acetaminophen and benzhydrocodone hydrochloride)
  Treatment for: Pain
• Arcoxia (etoricoxib)
  Treatment for: Osteoarthritis
• Arxxant (ruboxistaurin mesylate)
  Treatment for: Diabetic Retinopathy
• Axanum (aspirin and esomeprazole)
  Treatment for: NSAID-Induced Ulcer Prophylaxis, Ischemic Stroke, Prophylaxis
• baricitinib
  Treatment for: Rheumatoid Arthritis
• BHR-100 (progesterone)
  Treatment for: Head Injury
• bictegravir, emtricitabine and tenofovir alafenamide
  Treatment for: HIV Infection
• Bifeprunox
  Treatment for: Schizophrenia
• Bilastine
  Treatment for: Allergic Rhinitis
• binimetinib
  Treatment for: Melanoma, Metastatic
• BiovaxID
  Treatment for: Non-Hodgkin's Lymphoma
• Bonefos (clodronate)
  Treatment for: Breast Cancer, Adjuvant
• brincidofovir
  Treatment for: Ebola Virus Disease
• Calmactin (cilansetron)
  Treatment for: Irritable Bowel Syndrome
• Carbavance (meropenem and vaborbactam)
  Treatment for: Urinary Tract Infection
• ceftobiprole
  Treatment for: Skin and Structure Infection
• Ceplene (histamine dihydrochloride)
  Treatment for: Acute Myeloid Leukemia
• Certriad (rosuvastatin calcium and fenofibric acid)
  Treatment for: High Cholesterol, Hypertriglyceridemia, Hyperlipoproteinemia
• Chemophase (recombinant human hyaluronidase)
  Treatment for: Chemoadjuvant
• Ciltyri (eplivanserin)
  Treatment for: Insomnia
• Cinvanti (aprepitant)
  Treatment for: Nausea/Vomiting, Chemotherapy Induced
• Civanex (zucapsaicin)
  Treatment for: Osteoarthritis
• CL-108 (acetaminophen, hydrocodone and promethazine)
  Treatment for: Pain, Nausea/Vomiting
• cladribine
  Treatment for: Multiple Sclerosis
• CloniBID (clonidine hydrochloride)
  Treatment for: High Blood Pressure
• Clonicel (clonidine)
  Treatment for: ADHD
• Combidex (ferumoxtran-10)
  Treatment for: Body Imaging
• Comfyde (carisbamate)
  Treatment for: Seizures
• Coprexa (tetrathiomolybdate)
  Treatment for: Wilson's Disease
• corifollitropin alfa
  Treatment for: Female Infertility
• CorVue (binodenoson)
  Treatment for: Diagnosis and Investigation
• CTL019 (tisagenlecleucel-T)
  Treatment for: Acute Lymphoblastic Leukemia
• Davanat
  Treatment for: Targeted Drug Delivery
• DB289 (pafuramidine)
  Treatment for: Pneumocystis Pneumonia
• DE-109 (sirolimus)
  Treatment for: Uveitis
• Dextenza (dexamethasone)
  Treatment for: Postoperative Ocular Inflammation
• Dexycu (dexamethasone)
  Treatment for: Postoperative Ocular Inflammation
• Dimericine (T4N5 Liposome Lotion)
  Treatment for: Skin Cancer
• Dolizem (diltiazem hydrochloride)
  Treatment for: Anal Fissure and Fistula
• dolutegravir and rilpivirine
  Treatment for: HIV Infection
• DSUVIA (sufentanil)
  Treatment for: Pain
• Duzallo (allopurinol and lesinurad)
  
• Emezine (prochlorperazine)
  Treatment for: Nausea/Vomiting
• enasidenib
  Treatment for: Acute Myeloid Leukemia
• Enhanze SC (recombinant human hyaluronidase)
  Treatment for: Drug Delivery
• entrectinib
  Treatment for: Neuroblastoma
• erenumab
  Treatment for: Migraine Prevention
• ertugliflozin
  Treatment for: Diabetes, Type 2
• Evenity (romosozumab)
  Treatment for: Osteoporosis
• Exanta (ximelagatran)
  Treatment for: Prevention of Thromboembolism in Atrial Fibrillation
• Exelbine (vinorelbine)
  Treatment for: Non-Small Cell Lung Cancer
• Extravan (travoprost and timolol )
  Treatment for: Glaucoma
• EZR-104 (valsartan)
  Treatment for: High Blood Pressure, Heart Failure
• Fablyn (lasofoxifene tartrate)
  Treatment for: Osteoporosis
• Firdapse (amifampridine phosphate)
  Treatment for: Lambert Eaton Myasthenic Syndrome (LEMS); Congenital Myasthenic Syndromes (CMS)
• fluticasone furoate, umeclidinium and vilanterol
  Treatment for: COPD
• Flutiform (fluticasone and formoterol)
  Treatment for: Asthma
• Fluviral (influenza vaccine)
  Treatment for: Influenza Prophylaxis
• galeterone
  Treatment for: Prostate Cancer
• Galvus (vildagliptin)
  Treatment for: Diabetes, Type 2
• Garenoxacin
  Treatment for: Bacterial Infection
• Genasense (oblimersen sodium)
  Treatment for: Chronic Lymphocytic Leukemia
• Gencaro (bucindolol)
  Treatment for: Heart Failure
• gevokizumab
  Treatment for: Uveitis
• glecaprevir and pibrentasvir
  Treatment for: Hepatitis C
• Heplisav-B (hepatitis b adult vaccine)
  Treatment for: Hepatitis B Prevention
• HyQ (immune globulin and recombinant human hyaluronidase)
  Treatment for: Primary Immunodeficiency Syndrome
• iclaprim
  Treatment for: Skin and Structure Infection
• idebenone
  Treatment for: Duchenne Muscular Dystrophy
• Imagify (perflubutane)
  Treatment for: Diagnosis and Investigation
• IMGN529
  Treatment for: Non-Hodgkin's Lymphoma
• Inbrija (levodopa)
  Treatment for: Parkinson's Disease
• Indiplon (NBI-34060)
  Treatment for: Insomnia
• inotuzumab ozogamicin
  Treatment for: Acute Lymphoblastic Leukemia
• Intrinsa (testosterone)
  Treatment for: Female Sexual Dysfunction
• Jatenzo (testosterone undecanoate)
  Treatment for: Hypogonadism, Male
• JZP-6 (sodium oxybate)
  Treatment for: Fibromyalgia
• KedRAB (rabies immunoglobulin human)
  Treatment for: Rabies
• Kiacta (eprodisate)
  Treatment for: Amyloid A Amyloidosis
• KIT-302 (amlodipine and celecoxib)
  Treatment for: High Blood Pressure, Osteoarthritis
• KRN5500
  Treatment for: Chronic Chemotherapy Induced Peripheral Neuropathy
• KTE-C19 (axicabtagene ciloleucel)
  Treatment for: Non-Hodgkin's Lymphoma
• KW-6002 (istradefylline)
  Treatment for: Parkinson's Disease
• Kynapid (vernakalant)
  Treatment for: Atrial Fibrillation
• Kyndrisa (drisapersen)
  Treatment for: Duchenne Muscular Dystrophy
• KYTH-105 (setipiprant)
  Treatment for: Androgenetic Alopecia
• L-MTP-PE (mifamurtide)
  Treatment for: Osteosarcoma
• laquinimod
  Treatment for: Multiple Sclerosis, Huntington's Disease
• larotrectinib
  
• LEP-ETU (Liposome Entrapped Paclitaxel )
  Treatment for: Ovarian Cancer
• Lercanidipine
  Treatment for: High Blood Pressure
• Levadex (dihydroergotamine)
  Treatment for: Migraine
• LibiGel (testosterone)
  Treatment for: Hypoactive Sexual Desire Disorder
• Linjeta (human insulin [rDNA origin])
  Treatment for: Diabetes, Type 1, Diabetes, Type 2
• lixivaptan
  Treatment for: Hyponatremia
• Locilex (pexiganan)
  Treatment for: Diabetic Foot Infection
• loratadine and montelukast
  Treatment for: Allergic Rhinitis
• LPCN 1021 (testosterone)
  Treatment for: Hypogonadism, Male
• Lucassin (terlipressin)
  Treatment for: Hepatorenal Syndrome
• Lumigan Timolol (bimatoprost and timolol )
  Treatment for: Glaucoma
• Lutathera (lutetium Lu 177 dotatate)
  Treatment for: Neuroendocrine Carcinoma
• Luveniq (voclosporin)
  Treatment for: Uveitis
• LX1033
  Treatment for: Irritable Bowel Syndrome
• Macrilen (macimorelin acetate)
  Treatment for: Adult Human Growth Hormone Deficiency
• MBI-226 (omiganan pentahydrochloride)
  Treatment for: Infection Prophylaxis
• ME-344
  Treatment for: Ovarian Cancer, Small Cell Lung Cancer
• metadoxine
  Treatment for: ADHD
• migalastat
  Treatment for: Fabry Disease
• Miraxion (eicosapentaenoic acid (EPA))
  Treatment for: Huntington's Disease
• MK-0524A (niacin ER and laropiprant)
  Treatment for: Hyperlipoproteinemia Type IIa, Elevated LDL, Hypertriglyceridemia
• MK-1293
  Treatment for: Diabetes, Type 1, Diabetes, Type 2
• motavizumab
  Treatment for: Respiratory Syncytial Virus
• MoxDuo (morphine and oxycodone)
  Treatment for: Pain
• MQX-503
  Treatment for: Raynaud's Disease
• MT 100 (metoclopramide hydrochloride and naproxen sodium)
  Treatment for: Migraine
• Mucinex with Codeine (guaifenesin and codeine phosphate )
  Treatment for: Cough
• MuGard
  Treatment for: Mucositis
• Mycapssa (octreotide)
  Treatment for: Acromegaly
• MYL-1401O (trastuzumab)
  Treatment for: Breast Cancer
• naproxcinod
  Treatment for: Duchenne Muscular Dystrophy
• Naturlose (tagatose)
  Treatment for: Diabetes, Type 2
• neratinib
  Treatment for: Breast Cancer, Adjuvant
• NKTR-181
  Treatment for: Pain
• NOV-205
  Treatment for: Hepatitis C
• NT-0201 (amphetamine)
  Treatment for: ADHD
• Onconase (ranpirnase)
  Treatment for: Malignant Pleural Mesothelioma
• Onrigin (laromustine)
  Treatment for: Acute Myeloid Leukemia
• Opaxio (paclitaxel poliglumex)
  Treatment for: Non-Small Cell Lung Cancer, Ovarian Cancer, Glioblastoma Multiforme, Head and Neck Cancer
• OPN-375 (fluticasone)
  Treatment for: Nasal Polyps
• Orapem (faropenem medoxomil)
  Treatment for: Bacterial Infection
• Orathecin (rubitecan)
  Treatment for: Pancreatic Cancer
• orBec (beclomethasone dipropionate)
  Treatment for: Intestinal Graft-versus-Host Disease (iGVHD)
• Ostora (calcitonin)
  Treatment for: Osteoporosis
• OT-730
  Treatment for: Glaucoma
• Oxyprim (oxypurinol)
  Treatment for: Gout
• ozanimod
  Treatment for: Multiple Sclerosis, Ulcerative Colitis
• ozenoxacin
  Treatment for: Impetigo
• pacritinib
  Treatment for: Myelofibrosis
• Pancrecarb (pancrelipase)
  Treatment for: Pancreatic Exocrine Dysfunction
• Parecoxib
  Treatment for: Pain
• Pargluva (muraglitazar)
  Treatment for: Diabetes, Type 2
• Pixuvri (pixantrone)
  Treatment for: Non-Hodgkin's Lymphoma
• Plenvu (polyethylene glycol)
  Treatment for: Bowel Preparation
• Plumiaz (diazepam)
  Treatment for: Epilepsy
• PolyHeme (human hemoglobin)
  Treatment for: Bleeding Disorder
• Preos (parathyroid hormone (PTH 1-84))
  Treatment for: Osteoporosis
• Prexige (lumiracoxib)
  Treatment for: Osteoarthritis
• Priligy (dapoxetine)
  Treatment for: Premature Ejaculation
• Prochymal
  Treatment for: Graft-versus-host disease
• Prolacria (diquafosol tetrasodium)
  Treatment for: Dry Eye
• Pulminiq (cyclosporine)
  Treatment for: Organ Transplant, Rejection Prophylaxis
• Pulzium (tedisamil)
  Treatment for: Atrial Flutter, Atrial Fibrillation
• PW2101
  Treatment for: High Blood Pressure, Angina
• Qapzola (apaziquone)
  Treatment for: Bladder Cancer
• rapastinel
  Treatment for: Depression
• Remoxy (oxycodone)
  Treatment for: Pain
• Reolysin (pelareorep)
  Treatment for: Ovarian Cancer, Pancreatic Cancer, Malignant Glioma
• Replagal (agalsidase alfa)
  Treatment for: Fabry Disease
• Restanza (cethromycin)
  Treatment for: Pneumonia
• Retaane (anecortave acetate)
  Treatment for: Macular Degeneration
• Rexista (oxycodone hydrochloride)
  Treatment for: Pain
• Rezonic (casopitant)
  Treatment for: Nausea/Vomiting, Chemotherapy Induced, Nausea/Vomiting, Postoperative
• RG1068 (synthetic human secretin)
  
• Rhopressa (netarsudil)
  Treatment for: Glaucoma
• ridaforolimus
  Treatment for: Soft Tissue Sarcoma, Osteosarcoma
• Riquent (abetimus sodium)
  Treatment for: Systemic Lupus Erythematosus
• rociletinib
  Treatment for: Non-Small Cell Lung Cancer
• RSR13 (efaproxiral)
  Treatment for: Brain Metastases in patients with Breast Cancer
• Saforis (glutamine)
  Treatment for: Mucositis
• Sanvar (vapreotide acetate)
  Treatment for: Esophageal Varices with Bleeding
• Satraplatin
  Treatment for: Prostate Cancer
• Sefelsa (gabapentin)
  Treatment for: Postmenopausal Symptoms
• semaglutide
  Treatment for: Diabetes, Type 2
• SequestOx (naltrexone and oxycodone hydrochloride)
  Treatment for: Pain
• Serdolect (sertindole)
  Treatment for: Schizophrenia
• SGX942 (dusquetide)
  Treatment for: Mucositis
• SGX943 (dusquetide)
  Treatment for: Melioidosis
• SHP465
  Treatment for: ADHD
• sirukumab
  
• SnET2-PDT (Tin ethyl etiopurpurin (SnET2) photodynamic therapy (PDT))
  Treatment for: Macular Degeneration
• sofosbuvir, velpatasvir and voxilaprevir
  Treatment for: Hepatitis C
• Solithera (solithromycin)
  Treatment for: Pneumonia
• Solosec (secnidazole)
  Treatment for: Bacterial Vaginitis
• Sparlon (modafinil)
  Treatment for: ADHD in Children and Adolescents
• SparVax (recombinant Protective Antigen (rPA) anthrax vaccine)
  Treatment for: Anthrax Prophylaxis
• ST-246
  Treatment for: Exposure to Smallpox Virus
• T-Pred (tobramycin and prednisolone)
  Treatment for: Ocular Inflammation
• Tavalisse (fostamatinib)
  Treatment for: Immune Thrombocytopenia
• Tazarotene
  Treatment for: Psoriasis
• Tcelna (imilecleucel-T)
  Treatment for: Multiple Sclerosis
• Thelin (sitaxsentan)
  Treatment for: Pulmonary Hypertension
• Tibolone
  Treatment for: Perimenopausal Symptoms
• tildrakizumab
  Treatment for: Plaque Psoriasis
• tivozanib
  Treatment for: Renal Cell Carcinoma
• Tonmya (cyclobenzaprine hydrochloride)
  Treatment for: Post Traumatic Stress Disorder
• ToprolXL/Hydrochlorothiazide (metoprolol succinate and hydrochlorothiazide)
  Treatment for: High Blood Pressure
• toremifene
  Treatment for: Prevention of Fractures
• Translarna (ataluren)
  Treatment for: Duchenne Muscular Dystrophy
• Travivo (gepirone)
  Treatment for: Depression
• Trevyent (treprostinil)
  Treatment for: Pulmonary Arterial Hypertension
• triheptanoin
  Treatment for: Glucose Transporter Type-1 Deficiency Syndrome
• Trizytek (liprotamase)
  Treatment for: Pancreatic Exocrine Dysfunction
• Twirla (ethinyl estradiol and levonorgestrel)
  Treatment for: Birth Control
• Vadova (carbidopa and levodopa)
  Treatment for: Parkinson's Disease
• Vesneo (latanoprostene bunod)
  Treatment for: Glaucoma, Open Angle, Intraocular Hypertension
• Virulizin
  Treatment for: Pancreatic Cancer
• Vitaros (alprostadil)
  Treatment for: Erectile Dysfunction
• Viviant (bazedoxifene)
  Treatment for: Prevention of Osteoporosis
• Vyndaqel (tafamidis meglumine)
  Treatment for: Transthyretin Familial Amyloid Polyneuropathy; Transthyretin Cardiomyopathy
• Vyxeos (cytarabine and daunorubicin)
  Treatment for: Acute Myeloid Leukemia
• WC 3016
  Treatment for: Birth Control
• Xcytrin (motexafin gadolinium)
  Treatment for: Lung Cancer Brain Metastases
• Xinlay (atrasentan)
  Treatment for: Prostate Cancer
• Yonsa (abiraterone acetate)
  Treatment for: Prostate Cancer
• Yuvvexy (estradiol)
  Treatment for: Dyspareunia
• Zalbin (albinterferon alfa-2b)
  Treatment for: Hepatitis C
• Zalviso (sufentanil)
  Treatment for: Pain
• Zarnestra (tipifarnib)
  Treatment for: Acute Myeloid Leukemia
• Zensana (ondansetron hydrochloride)
  Treatment for: Nausea/Vomiting, Chemotherapy Induced
• Zilretta (triamcinolone acetonide)
  Treatment for: Osteoarthritis
• Zimulti (rimonabant)
  Treatment for: Obesity
• ZMapp
  Treatment for: Ebola Virus Disease
• ZS-9 (sodium zirconium cyclosilicate)
  Treatment for: Hyperkalemia
• ZTlido (lidocaine)
  Treatment for: Postherpetic Neuralgia