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Drug list Gene and cellular therapies NONE Biosimilars None Specialty Traditional 5-FU 5-fluorouracil 6MWD 6-minute walking distance 6MWT 6-minute walking test AA Accelerated Approval ABSSSI acute bacterial skin and skin structure infection ACC American College of Cardiology ACEI angiotensin-converting enzyme inhibitor AChR acetylcholine receptor ACR20 American College of Rheumatology 20% improvement ACR50 American College of Rheumatology 50% improvement ACR70 American College of Rheumatology 70% improvement ADC antibody-drug conjugate ADHD attention deficit hyperactivity disorder ADL activities of daily living ALK anaplastic lymphoma kinase ALK+ anaplastic lymphoma kinase-positive ALL acute lymphoblastic leukemia ALS amyotrophic lateral sclerosis ALSFRS-R Amyotrophic Lateral Sclerosis Functional Rating Scale-revised ALT alanine transaminase AMD age-related macular degeneration AML acute myeloid leukemia ANCA antineutrophil cytoplasmic antibodies APOE4 apolipoprotein E4 gene variant ARB angiotensin II receptor blocker ARNI angiotensin receptor II blocker neprilysin inhibitor AS ankylosing spondylitis ASCVD atherosclerotic cardiovascular disease AST aspartate aminotransferase BCG Bacillus Calmette-Gurin BCVA best corrected visual acuity BLA biologics license application BMI body mass index BMT bone marrow transplant BP blood pressure BPH benign prostatic hyperplasia BRAF v-raf murine sarcoma viral oncogene homolog B1 BT Breakthrough Therapy BTK Bruton's tyrosine kinase BSA body surface area BsUFA Biosimilar User Fee Act C-met c-mesenchymal-epithelial transition CABP community acquired bacterial pneumonia CAP community acquired pneumonia CAR T chimeric antigen receptor t-cell CD Crohn's disease CD3 cluster of differentiation 3 CD19 cluster of differentiation 19 CD20 cluster of differentiation 20 CD34 cluster of differentiation 34 CD38 cluster of differentiation 38 CD52 cluster of differentiation 52 CD79b cluster of differentiation 79b CDC Centers for Disease Control and Prevention CF cystic fibrosis CFTR cystic fibrosis transmembrane conductance regulator CHF congestive heart failure CI confidence interval CIS carcinoma in situ CKD chronic kidney disease CLDN18.2+ claudin-18.2-positive CLL chronic lymphocytic leukemia CML chronic myeloid leukemia CMS Centers for Medicare & Medicaid Services CMV cytomegalovirus CNPV Commissioner's National Priority Voucher CNS central nervous system COPD chronic obstructive pulmonary disease COVID-19 coronavirus disease 2019 CRC colorectal cancer CRL Complete Response Letter CRR complete response rate CRS cytokine release syndrome CRSwNP chronic rhinosinusitis with nasal polyps CSF colony stimulating factor CT scan computed tomography scan CTLA-4 cytotoxic t-lymphocyte-associated protein 4 CV cardiovascular CVD cardiovascular disease CYP3A4 cytochrome P-450 3A4 CYP450 cytochrome P-450 D-VRd bortezomib, lenalidomide and dexamethasone DAS28-CRP Disease Activity Score-28 with C reactive protein DBP diastolic blood pressure DCR disease control rate DEA Drug Enforcement Administration DED dry eye disease DLBCL diffuse large B cell lymphoma DMARD disease modifying antirheumatic drug DMD Duchenne muscular dystrophy DME diabetic macular edema dMMR DNA mismatch repair DMT disease modifying therapy DNA deoxyribonucleic acid DOR duration of response DPP-4 dipeptidyl peptidase 4 DR delayed release DSM-5 Diagnostic and Statistical Manual of Mental Disorders, 5th edition EASI-75 Eczema Area and Severity Index 75% reduction ERBB2 erythroblastic oncogene B-2 ECOG Eastern Cooperative Oncology Group eGFR estimated glomerular filtration rate EGFR epidermal growth factor receptor ER extended release ERA endothelin receptor agonist ERK extracellular signal-regulated kinase ERT endocrine receptor therapy ESA erythropoietin stimulating agent ESR1 estrogen receptor 1 ESRD end-stage renal disease EUA Emergency Use Authorization FDA Food and Drug Administration FEV1 force expiratory volume in 1 second FH familial hypercholesterolemia FLT3 FMS-like tyrosine kinase-3 FMS feline McDonough sarcoma FT Fast Track FVC forced vital capacity GABA-A gamma-aminobutyric acid receptor type A GALV-GP-R- gibbon ape leukemia virus glycoprotein G-CSF granulocyte colony stimulating factor GERD gastroesophageal reflux disease GGT gamma-glutamyl transferase GI gastrointestinal GIST gastrointestinal stromal tumor GLP-1RA glucagon-like peptide-1 receptor agonist GM-CSF granulocyte-macrophage colony stimulating factor GVHD graft versus host disease H half H3 K27M histone 3 lysine 27-to-methionine HAE hereditary angioedema HAM-A Hamilton Anxiety Rating Scale HAM-D Hamilton Depression Rating Scale HAMD-17 Hamilton Depression Rating Scale HAP healthcare-associated pneumonia Hb hemoglobin Hba1c hemoglobin a1c HBV hepatitis B virus HCC hepatocellular carcinoma HCP healthcare professional HCV hepatitis C virus HDRS-17 Hamilton Depression Rating Scale HeFH heterozygous familial hypercholesterolemia HER human epidermal growth factor receptor HER2 human epidermal growth factor receptor 2 HER2- human epidermal growth factor receptor 2-negative HER2+ human epidermal growth factor receptor 2-positive HF heart failure HFA hydrofluoroalkane HFpEF heart failure with preserved ejection fraction HFrEF heart failure with reduced ejection fraction HIT heparin induced thrombocytopenia HIV human immunodeficiency virus HIV-1 human immunodeficiency virus-1 HLA human leukocyte antigen HR hormone receptor HR- hormone receptor-negative HR+ hormone receptor-positive HoFH homozygous familial hypercholesterolemia HS hidradenitis suppurativa HSCT hematopoietic stem cell transplant HSV herpes simplex virus HTN hypertension IBS irritable bowel syndrome IBS-C irritable bowel syndrome, constipation predominant ICER Institute for Clinical and Economic Review ICS inhaled corticosteroid IDH isocitrate dehydrogenase IGA Investigator's Global Assessment Iga immunoglobulin A Igg immunoglobulin G Igg1 immunoglobulin G1 Igg4 immunoglobulin G4 IHC immunohistochemistry IL-3 interleukin-3 IL-4 interleukin-4 IL-5 interleukin-5 IL-8 interleukin-8 IL-12 interleukin-12 IL-13 interleukin-13 IL-17 interleukin-17 IL-23 interleukin-23 IL-31 interleukin-31 IM intramuscular IR immediate-release IRB institutional review board ISH in situ hybridization ITP immune thrombocytopenic purpura ITT intent-to-treat IV intravenous JAK Janus kinase inhibitor JIA juvenile idiopathic arthritis KIT c-kit proto-oncogene KMT2A lysine (k)-specific methyltransferase 2A KRAS Kirsten rat sarcoma viral oncogene homolog LABA long-acting beta agonist LAG-3 lymphocyte-activation gene 3 LAMA long-acting muscarinic antagonist LDL-C low-density lipoprotein cholesterol LPAD Limited Population Pathway for Antibacterial and Antifungal Drugs LRP4 low-density lipoprotein receptor-related protein 4 LSM least square mean LVAD left ventricular assist device LVEF left ventricular ejection fraction Mab monoclonal antibody MACE major adverse cardiovascular events MADRS Montgomerysberg Depression Rating Scale MAPK mitogen-activated protein kinase MASH metabolic dysfunction-associated steatohepatitis MDD major depressive disorder MDI metered dose inhaler MDR multi-drug resistant MECP2 methyl-CpG binding protein 2 MEK mitogen-activated extracellular signal-regulated kinase MET mesenchymal-epithelial transition MI myocardial infarction mITT modified intent-to-treat MRI magnetic resonance imaging mRNA messenger ribonucleic acid MRSA methicillin-resistant staphylococcus aureus MS multiple sclerosis MSI-H microsatellite instability-high mTOR mechanistic target of rapamycin MuSK muscle-specific tyrosine kinase N/A not applicable NAFLD nonalcoholic fatty liver disease NASH non-alcoholic steatohepatitis NCCN National Comprehensive Cancer Network NCT National Clinical Trial NDA new drug application NHL non-hodgkin lymphoma NIH National Institutes of Health NPM 1 nucleophosmin 1 nr-axSpA non-radiographic axial spondyloarthritis NRAS neuroblastoma RAS proto-oncogene NRG1+ neuregulin-1-positive NSAID non-steroidal anti-inflammatory drug NSCLC non-small cell lung cancer NTRK neurotrophic tyrosine receptor kinase NYHA New York Heart Association OD Orphan Drug ODT orally disintegrating tablet OR odds ratio ORR objective response rate OS overall survival OSA obstructive sleep apnea OTC over-the-counter PAD peripheral arterial disease PAH pulmonary arterial hypertension PARP poly (adp-ribose) polymerase PAS prior approval supplement PASI psoriasis area and severity index PASI 50 Psoriasis Area and Severity Index 50% reduction PASI 75 Psoriasis Area and Severity Index 75% reduction PASI 90 Psoriasis Area and Severity Index 90% reduction PASI 100 Psoriasis Area and Severity Index 100% reduction PCI percutaneous coronary intervention PCSK9 proprotein convertase subtilisin kexin 9 PD-1 programmed death protein 1 PD-L1 programmed death-ligand 1 PDE3 phosphodiesterase 3 PDE4 phosphodiesterase 4 PDE5 phosphodiesterase 5 PDUFA Prescription Drug User Fee Application PFS progression-free survival PGA Physician Global Assessment PHI primary humoral immunodeficiency PI3K phosphatidylinositol-3-kinase PNH paroxysmal nocturnal hemoglobinuria PR Priority Review PsA psoriatic arthritis PSO plaque psoriasis PTCA percutaneous transluminal coronary angioplasty PTSD post-traumatic stress disorder Q quarter QIDP Qualified Infectious Diseases Product QOL quality of life R/R relapsed or refractory R-CHOP rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone RA rheumatoid arthritis RAF rapidly accelerated fibrosarcoma RARA retinoic acid receptor alpha RBC red blood cell RCC renal cell carcinoma RECIST Response Evaluation Criteria in Solid Tumors REMS Risk Evaluation and Mitigation Strategy RMAT Regenerative Medicine Advanced Therapy RNA ribonucleic acid ROS1 ROS proto-oncogene 1 RPD Rare Pediatric Disease RRR relative risk reduction RSV respiratory syncytial virus RTOR Real-Time Oncology Review RVO retinal vein occlusion SARS-CoV-2 severe acute respiratory syndrome-associated coronavirus-2 sBLA supplemental biologics license application SBP systolic blood pressure SC subcutaneous SCCHN squamous cell cancer of the head and neck SCD sickle cell disease SCLC small cell lung cancer SCT stem cell transplant SGLT2 sodium-glucose co-transporter 2 SL sublingual SLE systemic lupus erythematosus SLL small lymphocytic lymphoma sNDA supplemental new drug application SNRI serotonin and norepinephrine reuptake inhibitor SOC standard of care SOD-1 superoxide dismutase-type 1 SPGA Static Physician Global Assessment SR sustained-release SSRI selective serotonin reuptake inhibitor SSSI skin and skin structure infection T1DM type 1 diabetes mellitus T2DM type 2 diabetes mellitus TBD to be determined TEAE treatment-emergent adverse event TKI tyrosine kinase inhibitor TNBC triple negative breast cancer TNF tumor necrosis factor TNF tumor necrosis factor-alpha UA unstable angina UC ulcerative colitis ULN upper limit of normal U.S