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Alphabetical Listing of all New Drug Applications
- 1UO (uracil)
Treatment for: Hand-Foot Syndrome - ABBV-951 (foscarbidopa and foslevodopa)
Treatment for: Parkinson's Disease - ABP 710 (biosimilar infliximab)
Treatment for: Rheumatoid Arthritis, Plaque Psoriasis, Crohn's Disease, Maintenance, Ulcerative Colitis, Psoriatic Arthritis, Ankylosing Spondylitis - acoramidis
Treatment for: Transthyretin Amyloid Cardiomyopathy - 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 - ALPHA-1062
Treatment for: Alzheimer's Disease - Ampligen (rintatolimod)
Treatment for: Chronic Fatigue Syndrome - Androxal (enclomiphene)
Treatment for: Hypogonadism, Male - Arcoxia (etoricoxib)
Treatment for: Osteoarthritis - arimoclomol
Treatment for: Niemann-Pick Disease - Arxxant (ruboxistaurin mesylate)
Treatment for: Diabetic Retinopathy - atacicept
Treatment for: Nephropathy - atrasentan
Treatment for: Nephropathy - avasopasem manganese
Treatment for: Mucositis - 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 - 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 - crovalimab
Treatment for: Paroxysmal Nocturnal Hemoglobinuria - 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 - Davanat
Treatment for: Targeted Drug Delivery - DB289 (pafuramidine)
Treatment for: Pneumocystis Pneumonia - DE-109 (sirolimus)
Treatment for: Uveitis - deuruxolitinib
Treatment for: Alopecia Areata - DFD-29 (minocycline hydrochloride)
Treatment for: Rosacea - Dimericine (T4N5 Liposome Lotion)
Treatment for: Skin Cancer - Dolizem (diltiazem hydrochloride)
Treatment for: Anal Fissure and Fistula - donanemab
Treatment for: Alzheimer's Disease - 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 - elafibranor
Treatment for: Primary Biliary Cholangitis - elamipretide
Treatment for: Barth Syndrome - Emezine (prochlorperazine)
Treatment for: Nausea/Vomiting - Enhanze SC (recombinant human hyaluronidase)
Treatment for: Drug Delivery - ensartinib
Treatment for: Non-Small Cell Lung Cancer - ensifentrine
Treatment for: COPD, Maintenance - Esmya (ulipristal acetate)
Treatment for: Uterine Fibroids - ET-105 (lamotrigine)
- 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 - 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 - IB1001 (N-acetyl-L-leucine)
Treatment for: Niemann-Pick Disease - iclaprim
Treatment for: Skin and Structure Infection - idebenone
Treatment for: Duchenne Muscular Dystrophy - Imagify (perflubutane)
Treatment for: Diagnosis and Investigation - imetelstat
Treatment for: Myelodysplastic Syndrome - IMGN529
Treatment for: Non-Hodgkin's Lymphoma - Indiplon (NBI-34060)
Treatment for: Insomnia - Intrinsa (testosterone)
Treatment for: Female Sexual Dysfunction - IPX203 (carbidopa and levodopa)
Treatment for: Parkinson's Disease - Janssen COVID-19 Vaccine (SARS-CoV-2 vaccine)
Treatment for: Prevention of COVID-19 - JZP-6 (sodium oxybate)
Treatment for: Fibromyalgia - KarXT (xanomeline and trospium)
Treatment for: Schizophrenia; Alzheimer’s Disease Psychosis - 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 - landiolol
Treatment for: Supraventricular Tachycardia - 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
- linzagolix
Treatment for: Uterine Fibroids - lixivaptan
Treatment for: Hyponatremia - 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 - Lymphir (denileukin diftitox-cxdl)
Treatment for: Cutaneous T-cell Lymphoma - Lytenava (bevacizumab-vikg)
- marstacimab
Treatment for: Hemophilia A, Hemophilia B - 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 - neffy (epinephrine)
Treatment for: Anaphylaxis - nemolizumab
Treatment for: Prurigo Nodularis, Atopic Dermatitis - NKTR-181 (oxycodegol)
Treatment for: Pain - NOV-205
Treatment for: Hepatitis C - Novavax COVID-19 Vaccine (SARS-CoV-2 vaccine)
Treatment for: COVID-19 - NVK002 (atropine)
Treatment for: Myopia - Oclaiz (octreotide)
Treatment for: Acromegaly - odronextamab
Treatment for: Follicular Lymphoma, Diffuse Large B-Cell Lymphoma - 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 - 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 - Pixuvri (pixantrone)
Treatment for: Non-Hodgkin's Lymphoma - plinabulin
Treatment for: Neutropenia Associated with Chemotherapy - Plivensia (sirukumab)
Treatment for: Rheumatoid Arthritis - 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) - revumenib
Treatment for: Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia - 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 - Sefelsa (gabapentin)
Treatment for: Postmenopausal Symptoms - seladelpar
Treatment for: Primary Biliary Cholangitis - 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 - sulopenem
Treatment for: Bacterial Infection - surufatinib
Treatment for: Neuroendocrine Carcinoma - SYD985 ([vic-]trastuzumab duocarmazine)
Treatment for: Breast Cancer, Metastatic - T-Pred (tobramycin and prednisolone)
Treatment for: Ocular Inflammation - tanezumab
Treatment for: Osteoarthritis - Tazarotene
Treatment for: Psoriasis - Tcelna (imilecleucel-T)
Treatment for: Multiple Sclerosis - tebipenem hydrobromide
Treatment for: Urinary Tract Infection - Telitacicept
Treatment for: Rheumatoid Arthritis - Thelin (sitaxsentan)
Treatment for: Pulmonary Arterial Hypertension - Tibolone
Treatment for: Perimenopausal Symptoms - Tonmya (cyclobenzaprine hydrochloride)
Treatment for: Post Traumatic Stress Disorder, Fibromyalgia - ToprolXL/Hydrochlorothiazide (metoprolol succinate and hydrochlorothiazide)
Treatment for: High Blood Pressure - toremifene
Treatment for: Prevention of Fractures - tradipitant
Treatment for: Gastroparesis - TransCon PTH (palopegteriparatide)
Treatment for: Hypoparathyroidism - 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 - Upstaza (eladocagene exuparvovec)
Treatment for: Aromatic L-Amino Acid Decarboxylase (AADC) Deficiency - V116 (pneumococcal 21-valent conjugate vaccine)
Treatment for: Pneumococcal Disease Prophylaxis - Vadova (carbidopa and levodopa)
Treatment for: Parkinson's Disease - veverimer
Treatment for: Metabolic Acidosis - Viaskin Peanut (peanut immunotherapy)
Treatment for: Peanut Allergy - Vicineum (oportuzumab monatox-qqrs)
Treatment for: Bladder Cancer - Virulizin
Treatment for: Pancreatic Cancer - Vitaros (alprostadil)
Treatment for: Erectile Dysfunction - Viviant (bazedoxifene)
Treatment for: Prevention of Osteoporosis - vorasidenib
Treatment for: Malignant Glioma - 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 (PAH); Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD) - Zalbin (albinterferon alfa-2b)
Treatment for: Hepatitis C - Zalviso (sufentanil)
Treatment for: Pain - zanidatamab
Treatment for: Biliary Tract Tumor - Zarnestra (tipifarnib)
Treatment for: Acute Myeloid Leukemia - Zensana (ondansetron hydrochloride)
Treatment for: Nausea/Vomiting, Chemotherapy Induced - Zimulti (rimonabant)
Treatment for: Weight Loss (Obesity/Overweight) - ZMapp
Treatment for: Ebola Virus Disease - zolbetuximab
Treatment for: Gastric Cancer - Zyesami (aviptadil)
Treatment for: COVID-19 - Zygel (cannabidiol)
Treatment for: Behavioral Symptoms associated with Fragile X Syndrome