Alphabetical Listing of all New Drug Applications

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• 1UO (uracil)
  Treatment for: Hand-Foot Syndrome
• ABP 710 (biosimilar infliximab)
  Treatment for: Rheumatoid Arthritis, Plaque Psoriasis, Crohn's Disease, Maintenance, Ulcerative Colitis, Psoriatic Arthritis, Ankylosing Spondylitis
• ADL5859
  Treatment for: Pain
• Advexin (p53 tumor suppressor therapy)
  Treatment for: Head and Neck Cancer
• ADX-2191 (methotrexate)
  Treatment for: Primary Vitreoretinal Lymphoma
• ALKS 5461 (buprenorphine and samidorphan)
  Treatment for: Depression
• Ampligen (rintatolimod)
  Treatment for: Chronic Fatigue Syndrome
• Androxal (enclomiphene)
  Treatment for: Hypogonadism, Male
• Arcoxia (etoricoxib)
  Treatment for: Osteoarthritis
• Arxxant (ruboxistaurin mesylate)
  Treatment for: Diabetic Retinopathy
• atacicept
  Treatment for: Nephropathy
• atrasentan
  Treatment for: Nephropathy
• avasopasem manganese
  Treatment for: Mucositis
• avutometinib
  Treatment for: Ovarian Cancer
• Axanum (aspirin and esomeprazole)
  Treatment for: NSAID-Induced Ulcer Prophylaxis, Ischemic Stroke, Prophylaxis
• Aximris XR (oxycodone hydrochloride)
  Treatment for: Pain
• AXS-07 (meloxicam and rizatriptan)
  Treatment for: Migraine
• AZD1222 (SARS-CoV-2 vaccine)
  Treatment for: Prevention of COVID-19
• bamlanivimab
  Treatment for: COVID-19
• bamlanivimab and etesevimab
  Treatment for: COVID-19, Post-Exposure Prophylaxis of COVID-19
• bardoxolone
  Treatment for: Alport Syndrome
• bebtelovimab
  Treatment for: COVID-19
• BHR-100 (progesterone)
  Treatment for: Head Injury
• Bifeprunox
  Treatment for: Schizophrenia
• Bilastine
  Treatment for: Allergic Rhinitis
• BiovaxID
  Treatment for: Non-Hodgkin's Lymphoma
• Bonefos (clodronate)
  Treatment for: Breast Cancer, Adjuvant
• Brinavess (vernakalant)
  Treatment for: Atrial Fibrillation
• buprenorphine
  Treatment for: Pain
• Calmactin (cilansetron)
  Treatment for: Irritable Bowel Syndrome
• CAM2029 (octreotide)
  Treatment for: Acromegaly
• camrelizumab
  Treatment for: Hepatocellular Carcinoma
• Cardamyst (etripamil)
  Treatment for: Paroxysmal Supraventricular Tachycardia
• cefepime and taniborbactam
  Treatment for: Urinary Tract 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
• Civanex (zucapsaicin)
  Treatment for: Osteoarthritis
• CL-108 (acetaminophen, hydrocodone and promethazine)
  Treatment for: Pain, Nausea/Vomiting
• 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
• Contepo (fosfomycin)
  Treatment for: Urinary Tract Infection
• Coprexa (tetrathiomolybdate)
  Treatment for: Wilson's Disease
• corifollitropin alfa
  Treatment for: Female Infertility
• CorVue (binodenoson)
  Treatment for: Diagnosis and Investigation
• cosibelimab
  Treatment for: Squamous Cell Carcinoma
• Cosyntropin Depot
  Treatment for: Adrenocortical Insufficiency
• crenolanib
  Treatment for: Acute Myeloid Leukemia, Gastrointestinal Stromal Tumor
• danuglipron
  Treatment for: Weight Loss (Obesity/Overweight)
• dasotraline
  Treatment for: ADHD, Eating Disorders
• Dasynoc (dasatinib)
  Treatment for: Chronic Myelogenous Leukemia, Acute Lymphoblastic Leukemia
• datopotamab deruxtecan
  Treatment for: Non Small Cell Lung Cancer, Breast Cancer
• Davanat
  Treatment for: Targeted Drug Delivery
• DB289 (pafuramidine)
  Treatment for: Pneumocystis Pneumonia
• DCCR (diazoxide choline)
  Treatment for: Prader-Willi Syndrome
• DE-109 (sirolimus)
  Treatment for: Uveitis
• defactinib
  Treatment for: Ovarian Cancer
• delgocitinib
  Treatment for: Chronic Hand Eczema
• Dimericine (T4N5 Liposome Lotion)
  Treatment for: Skin Cancer
• Dolizem (diltiazem hydrochloride)
  Treatment for: Anal Fissure and Fistula
• donidalorsen
  Treatment for: Hereditary Angioedema
• dovitinib
  Treatment for: Renal Cell Carcinoma
• DPI-386 (scopolamine)
  Treatment for: Motion Sickness
• E4/DRSP (estetrol and drospirenone)
  Treatment for: Birth Control
• Edsivo (celiprolol)
  Treatment for: Vascular Ehlers-Danlos Syndrome
• elamipretide
  Treatment for: Barth Syndrome
• elinzanetant
  Treatment for: Hot Flashes, Menopausal Disorders
• Emezine (prochlorperazine)
  Treatment for: Nausea/Vomiting
• Enhanze SC (recombinant human hyaluronidase)
  Treatment for: Drug Delivery
• ensartinib
  Treatment for: Non Small Cell Lung Cancer
• Esmya (ulipristal acetate)
  Treatment for: Uterine Fibroids
• ET-105 (lamotrigine)
  
• ET-400 (hydrocortisone)
  Treatment for: Adrenocortical Insufficiency
• Evusheld (tixagevimab co-packaged with cilgavimab)
  Treatment for: Pre-Exposure Prophylaxis of COVID-19
• 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
• fexapotide triflutate
  Treatment for: Benign Prostatic Hyperplasia
• filgotinib
  Treatment for: Rheumatoid Arthritis
• 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
• gefapixant
  Treatment for: Cough
• Genasense (oblimersen sodium)
  Treatment for: Chronic Lymphocytic Leukemia
• Gencaro (bucindolol)
  Treatment for: Heart Failure
• gevokizumab
  Treatment for: Uveitis
• glepaglutide
  Treatment for: Short Bowel Syndrome
• GMRx2 (amlodipine, indapamide and telmisartan)
  Treatment for: High Blood Pressure
• Gohibic (vilobelimab)
  Treatment for: COVID-19
• govorestat
  Treatment for: Galactosemia
• Hepcludex (bulevirtide)
  Treatment for: Hepatitis D
• 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
• Indiplon (NBI-34060)
  Treatment for: Insomnia
• Intrinsa (testosterone)
  Treatment for: Female Sexual Dysfunction
• Janssen COVID-19 Vaccine (SARS-CoV-2 vaccine)
  Treatment for: Prevention of COVID-19
• JZP-6 (sodium oxybate)
  Treatment for: Fibromyalgia
• Kiacta (eprodisate)
  Treatment for: Amyloid A Amyloidosis
• KRN5500
  Treatment for: Chronic Chemotherapy Induced Peripheral Neuropathy
• Kyndrisa (drisapersen)
  Treatment for: Duchenne Muscular Dystrophy
• KYTH-105 (setipiprant)
  Treatment for: Androgenetic Alopecia
• L-MTP-PE (mifamurtide)
  Treatment for: Osteosarcoma
• Lagevrio (molnupiravir)
  Treatment for: COVID-19
• laquinimod
  Treatment for: Multiple Sclerosis, Huntington's Disease
• LEP-ETU (Liposome Entrapped Paclitaxel )
  Treatment for: Ovarian Cancer
• Lercanidipine
  Treatment for: High Blood Pressure
• leronlimab
  
• Levadex (dihydroergotamine)
  Treatment for: Migraine
• LibiGel (testosterone)
  Treatment for: Hypoactive Sexual Desire Disorder
• Linhaliq (ciprofloxacin liposomal)
  
• Linjeta (human insulin [rDNA origin])
  Treatment for: Diabetes, Type 1, Diabetes, Type 2
• linvoseltamab
  Treatment for: Multiple Myeloma
• linzagolix
  Treatment for: Uterine Fibroids
• lixivaptan
  Treatment for: Hyponatremia
• LNZ100 (aceclidine)
  Treatment for: Presbyopia
• Locilex (pexiganan)
  Treatment for: Diabetic Foot Infection
• loratadine and montelukast
  Treatment for: Allergic Rhinitis
• Lumigan Timolol (bimatoprost and timolol )
  Treatment for: Glaucoma
• Lusduna Nexvue (insulin glargine)
  Treatment for: Diabetes, Type 1, Diabetes, Type 2
• LV-101 (carbetocin)
  Treatment for: Prader-Willi Syndrome
• LX1033
  Treatment for: Irritable Bowel Syndrome
• Lytenava (bevacizumab-vikg)
  
• MBI-226 (omiganan pentahydrochloride)
  Treatment for: Infection Prophylaxis
• ME-344
  Treatment for: Ovarian Cancer, Small Cell Lung Cancer
• metadoxine
  Treatment for: ADHD
• midomafetamine
  Treatment for: Post Traumatic Stress Disorder
• Miraxion (eicosapentaenoic acid (EPA))
  Treatment for: Huntington's Disease
• mirdametinib
  Treatment for: Neurofibromatosis
• MK-0524A (niacin ER and laropiprant)
  Treatment for: Hyperlipoproteinemia Type IIa, Elevated LDL, Hypertriglyceridemia
• motavizumab
  Treatment for: RSV
• 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
• naproxcinod
  Treatment for: Duchenne Muscular Dystrophy
• narsoplimab
  Treatment for: Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy (HSCT-TMA)
• Naturlose (tagatose)
  Treatment for: Diabetes, Type 2
• nipocalimab
  Treatment for: Myasthenia Gravis
• NKTR-181 (oxycodegol)
  Treatment for: Pain
• NOV-205
  Treatment for: Hepatitis C
• Novavax COVID-19 Vaccine (SARS-CoV-2 vaccine)
  Treatment for: COVID-19
• NP001 (sodium chlorite)
  Treatment for: Amyotrophic Lateral Sclerosis
• NVK002 (atropine)
  Treatment for: Myopia
• odronextamab
  Treatment for: Follicular Lymphoma, Diffuse Large B-Cell Lymphoma
• olezarsen
  Treatment for: Familial Chylomicronemia Syndrome
• olorofim
  Treatment for: Fungal Infections
• omecamtiv mecarbil
  Treatment for: Heart Failure with Reduced Ejection Fraction
• Onconase (ranpirnase)
  Treatment for: Malignant Pleural Mesothelioma
• Onrigin (laromustine)
  Treatment for: Acute Myeloid Leukemia
• Ontinua ER (arbaclofen)
  Treatment for: Spasticity, Multiple Sclerosis
• Opaxio (paclitaxel poliglumex)
  Treatment for: Non Small Cell Lung Cancer, Ovarian Cancer, Glioblastoma Multiforme, Head and Neck Cancer
• Orapem (faropenem medoxomil)
  Treatment for: Bacterial Infection
• Orathecin (rubitecan)
  Treatment for: Pancreatic Cancer
• orBec (beclomethasone dipropionate)
  Treatment for: Intestinal Graft-versus-Host Disease (iGVHD)
• orforglipron
  Treatment for: Diabetes, Type 2, Weight Loss (Obesity/Overweight)
• Ostora (calcitonin)
  Treatment for: Osteoporosis
• OT-730
  Treatment for: Glaucoma
• OX124 (naloxone)
  Treatment for: Opioid Overdose
• oxylanthanum carbonate
  Treatment for: Hyperphosphatemia of Renal Failure
• Oxyprim (oxypurinol)
  Treatment for: Gout
• Parecoxib
  Treatment for: Pain
• Pargluva (muraglitazar)
  Treatment for: Diabetes, Type 2
• parsaclisib
  Treatment for: Non-Hodgkin's Lymphoma
• patritumab deruxtecan
  Treatment for: Non Small Cell Lung Cancer
• PDP-716 (brimonidine tartrate)
  Treatment for: Glaucoma, Open Angle, Glaucoma/Intraocular Hypertension
• pegzilarginase
  Treatment for: Arginase 1 Deficiency
• Pemgarda (pemivibart)
  Treatment for: Pre-Exposure Prophylaxis of COVID-19
• Pixclara (floretyrosine f-18)
  Treatment for: Diagnosis and Investigation
• Pixuvri (pixantrone)
  Treatment for: Non-Hodgkin's Lymphoma
• plinabulin
  Treatment for: Neutropenia Associated with Chemotherapy
• Plivensia (sirukumab)
  Treatment for: Rheumatoid Arthritis
• plozasiran
  Treatment for: Familial Chylomicronemia Syndrome
• PolyHeme (human hemoglobin)
  Treatment for: Bleeding Disorder
• poziotinib
  Treatment for: Non Small Cell Lung Cancer
• prademagene zamikeracel
  Treatment for: Epidermolysis Bullosa
• 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
• Qtrypta (zolmitriptan)
  Treatment for: Migraine
• rapastinel
  Treatment for: Depression
• REGEN-COV (casirivimab and imdevimab)
  Treatment for: COVID-19
• reltecimod
  Treatment for: Organ Dysfunction or Failure in Patients with Necrotizing Soft Tissue Infection
• Remoxy ER (oxycodone)
  Treatment for: Pain
• Reolysin (pelareorep)
  Treatment for: Ovarian Cancer, Pancreatic Cancer, Malignant Glioma
• Replagal (agalsidase alfa)
  Treatment for: Fabry Disease
• reproxalap
  Treatment for: Dry Eye Disease
• Restanza (cethromycin)
  Treatment for: Pneumonia
• Retaane (anecortave acetate)
  Treatment for: Macular Degeneration
• retatrutide
  Treatment for: Weight Loss (Obesity/Overweight)
• revakinagene taroretcel
  
• Rezonic (casopitant)
  Treatment for: Nausea/Vomiting, Chemotherapy Induced, Nausea/Vomiting, Postoperative
• RG1068 (synthetic human secretin)
  
• ridaforolimus
  Treatment for: Soft Tissue Sarcoma, Osteosarcoma
• Riquent (abetimus sodium)
  Treatment for: Lupus
• rivoceranib
  Treatment for: Hepatocellular Carcinoma
• rociletinib
  Treatment for: Non Small Cell Lung Cancer
• roluperidone
  Treatment for: Schizophrenia
• roxadustat
  Treatment for: Anemia Due to Chronic Kidney Disease
• 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
• sebetralstat
  Treatment for: Hereditary Angioedema
• Sefelsa (gabapentin)
  Treatment for: Postmenopausal Symptoms
• sepiapterin
  Treatment for: Phenylketonuria
• SequestOx (naltrexone and oxycodone hydrochloride)
  Treatment for: Pain
• Serdolect (sertindole)
  Treatment for: Schizophrenia
• SGX942 (dusquetide)
  Treatment for: Mucositis
• SGX943 (dusquetide)
  Treatment for: Melioidosis
• SGX945 (dusquetide)
  Treatment for: Behcet's Disease
• SHP465
  Treatment for: ADHD
• sintilimab
  Treatment for: Non Small Cell Lung Cancer
• SnET2-PDT (Tin ethyl etiopurpurin (SnET2) photodynamic therapy (PDT))
  Treatment for: Macular Degeneration
• Solithera (solithromycin)
  Treatment for: Pneumonia
• sotrovimab
  Treatment for: COVID-19
• Sparlon (modafinil)
  Treatment for: ADHD in Children and Adolescents
• SparVax (recombinant Protective Antigen (rPA) anthrax vaccine)
  Treatment for: Anthrax Prophylaxis
• SPN-830 (apomorphine)
  Treatment for: Hypomobility in Parkinson’s Disease
• ST-246
  Treatment for: Exposure to Smallpox Virus
• stannsoporfin
  Treatment for: Hyperbilirubinemia
• STS101 (dihydroergotamine mesylate)
  Treatment for: Migraine
• sunvozertinib
  Treatment for: Non Small Cell Lung Cancer
• surufatinib
  Treatment for: Neuroendocrine Carcinoma
• SYD985 ([vic-]trastuzumab duocarmazine)
  Treatment for: Breast Cancer, Metastatic
• T-Pred (tobramycin and prednisolone)
  Treatment for: Ocular Inflammation
• tabelecleucel
  Treatment for: EBV-Positive Post-Transplant Lymphoproliferative Disease
• tanezumab
  Treatment for: Osteoarthritis
• Tazarotene
  Treatment for: Psoriasis
• Tcelna (imilecleucel-T)
  Treatment for: Multiple Sclerosis
• tebipenem hydrobromide
  Treatment for: Urinary Tract Infection
• Teliso-V (telisotuzumab vedotin)
  Treatment for: Non Small Cell Lung Cancer
• Telitacicept
  Treatment for: Rheumatoid Arthritis
• Thelin (sitaxsentan)
  Treatment for: Pulmonary Arterial Hypertension
• Tibolone
  Treatment for: Perimenopausal Symptoms
• TNX-102 (cyclobenzaprine hydrochloride)
  Treatment for: Fibromyalgia
• ToprolXL/Hydrochlorothiazide (metoprolol succinate and hydrochlorothiazide)
  Treatment for: High Blood Pressure
• toremifene
  Treatment for: Prevention of Fractures
• tradipitant
  Treatment for: Gastroparesis
• Translarna (ataluren)
  Treatment for: Duchenne Muscular Dystrophy
• treosulfan
  Treatment for: Stem Cell Transplant Conditioning
• Trevyent (treprostinil)
  Treatment for: Pulmonary Arterial Hypertension
• Trizytek (liprotamase)
  Treatment for: Pancreatic Exocrine Dysfunction
• udenafil
  Treatment for: Single Ventricle Heart Disease
• UGN-102 (mitomycin)
  Treatment for: Bladder Cancer
• Vadova (carbidopa and levodopa)
  Treatment for: Parkinson's Disease
• vanzacaftor, tezacaftor and deutivacaftor
  Treatment for: Cystic Fibrosis
• veverimer
  Treatment for: Metabolic Acidosis
• Viaskin Peanut (peanut immunotherapy)
  Treatment for: Peanut Allergy
• Vicineum (oportuzumab monatox-qqrs)
  Treatment for: Bladder Cancer
• vimseltinib
  Treatment for: Tenosynovial Giant Cell Tumor
• Virulizin
  Treatment for: Pancreatic Cancer
• Vitaros (alprostadil)
  Treatment for: Erectile Dysfunction
• Viviant (bazedoxifene)
  Treatment for: Prevention of Osteoporosis
• VX-548 (suzetrigine)
  Treatment for: Neuropathic Pain, Pain, Postoperative Pain
• Waylivra (volanesorsen)
  Treatment for: Familial Chylomicronemia Syndrome
• WC 3016
  Treatment for: Birth Control
• Xcytrin (motexafin gadolinium)
  Treatment for: Lung Cancer Brain Metastases
• Xinlay (atrasentan)
  Treatment for: Prostate Cancer
• Yutrepia (treprostinil)
  Treatment for: Pulmonary Arterial Hypertension; Pulmonary Hypertension Associated with Interstitial Lung Disease
• Zalbin (albinterferon alfa-2b)
  Treatment for: Hepatitis C
• Zalviso (sufentanil)
  Treatment for: Pain
• Zarnestra (tipifarnib)
  Treatment for: Acute Myeloid Leukemia
• zenocutuzumab
  Treatment for: Non Small Cell Lung Cancer, Pancreatic Cancer
• Zensana (ondansetron hydrochloride)
  Treatment for: Nausea/Vomiting, Chemotherapy Induced
• Zimulti (rimonabant)
  Treatment for: Weight Loss (Obesity/Overweight)
• ZMapp
  Treatment for: Ebola Virus Disease
• Zyesami (aviptadil)
  Treatment for: COVID-19
• Zygel (cannabidiol)
  Treatment for: Behavioral Symptoms associated with Fragile X Syndrome
• Zynquista (sotagliflozin)
  Treatment for: Diabetes, Type 1