Leqembi (lecanemab-irmb) Injection

Date of Approval: January 6, 2023
Company: Biogen Inc. and Eisai Co., Ltd.
Treatment for: Alzheimer's Disease

Leqembi (lecanemab) is an amyloid beta-directed antibody indicated for the treatment of Alzheimer’s disease.

FDA Approves Leqembi (lecanemab-irmb) Under the Accelerated Approval Pathway for the Treatment of Alzheimer's Disease
Leqembi (lecanemab-irmb) FDA Approval History

Airsupra (albuterol and budesonide) Inhalation Aerosol

Date of Approval: January 10, 2023
Company: AstraZeneca Pharmaceuticals LP
Treatment for: Asthma

Airsupra (albuterol and budesonide) is a beta2-adrenergic agonist and corticosteroid fixed-dose combination rescue inhaler for as-needed use to reduce the risk of asthma exacerbations.

Rykindo (risperidone) for Extended-Release Injectable Suspension

Date of Approval: January 13, 2023
Company: Luye Pharma Group
Treatment for: Schizophrenia, Bipolar Disorder

Rykindo (risperidone) is a long-acting injection formulation of the approved atypical antipsychotic risperidone for the treatment of schizophrenia and bipolar I disorder in adults.

Brenzavvy (bexagliflozin) Tablets

Date of Approval: January 20, 2023
Company: TheracosBio, LLC
Treatment for: Diabetes, Type 2

Brenzavvy (bexagliflozin) is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Jaypirca (pirtobrutinib) Tablets

Date of Approval: January 27, 2023
Company: Eli Lilly and Company
Treatment for: Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia

Jaypirca (pirtobrutinib) is a non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor for use in the treatment of mantle cell lymphoma (MCL), and chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL).

Orserdu (elacestrant) Tablets

Date of Approval: January 27, 2023
Company: Menarini Group
Treatment for: Breast Cancer

Orserdu (elacestrant) is an estrogen receptor antagonist indicated for the treatment of postmenopausal women or adult men, with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

Jesduvroq (daprodustat) Tablets

Date of Approval: February 1, 2023
Company: GlaxoSmithKline
Treatment for: Anemia Due to Chronic Kidney Disease

Jesduvroq (daprodustat) is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) for the treatment of patients with anemia of chronic kidney disease (CKD).

Lamzede (velmanase alfa-tycv) Lyophilized Powder for Injection

Date of Approval: February 16, 2023
Company: Chiesi Global Rare Diseases
Treatment for: Alpha-Mannosidosis

Lamzede (velmanase-alfa-tycv) is recombinant human lysosomal alpha-mannosidase indicated for the treatment of non-central nervous system manifestations of alpha-mannosidosis.

Filspari (sparsentan) Tablets

Date of Approval: February 17, 2023
Company: Travere Therapeutics, Inc.
Treatment for: Primary Immunoglobulin A Nephropathy

Filspari (sparsentan) is an endothelin and angiotensin II receptor antagonist indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy.

Syfovre (pegcetacoplan) Injection

Date of Approval: February 17, 2023
Company: Apellis Pharmaceuticals, Inc.
Treatment for: Macular Degeneration

Syfovre (pegcetacoplan) is a complement inhibitor indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Altuviiio (antihemophilic factor recombinant, Fc-VWF-XTEN fusion protein-ehtl) Lyophilized Powder for Injection

Date of Approval: February 22, 2023
Company: Sanofi
Treatment for: Hemophilia A

Altuviiio [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl] is a recombinant DNA-derived, factor VIII concentrate indicated for use in people with hemophilia A.

Skyclarys (omaveloxolone) Capsules

Date of Approval: February 28, 2023
Company: Reata Pharmaceuticals, Inc.
Treatment for: Friedreich’s Ataxia

Skyclarys (omaveloxolone) is an activator of Nrf2 (nuclear factor erythroid 2–related factor 2) for the treatment of Friedreich’s ataxia.

Zavzpret (zavegepant) Nasal Spray

Date of Approval: March 9, 2023
Company: Pfizer Inc.
Treatment for: Migraine

Zavzpret (zavegepant) is a calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the acute treatment of migraine.

Daybue (trofinetide) Oral Solution

Date of Approval: March 10, 2023
Company: Acadia Pharmaceuticals Inc.
Treatment for: Rett Syndrome

Daybue (trofinetide) is a synthetic analog of the amino‐terminal tripeptide of IGF-1 for the treatment of Rett syndrome.

Zynyz (retifanlimab-dlwr) Injection

Date of Approval: March 22, 2023
Company: Incyte
Treatment for: Merkel Cell Carcinoma

Zynyz (retifanlimab-dlwr) is a programmed death receptor-1 (PD-1)-blocking antibody for the treatment of Merkel cell carcinoma.

Rezzayo (rezafungin) Powder for Injection

Date of Approval: March 22, 2023
Company: Cidara Therapeutics, Inc.
Treatment for: Candidemia, Systemic Candidiasis

Rezzayo (rezafungin) is an echinocandin antifungal used for the treatment of candidemia and invasive candidiasis.

Joenja (leniolisib) Tablets

Date of Approval: March 24, 2023
Company: Pharming Group N.V.
Treatment for: Activated PI3K-Delta Syndrome

Joenja (leniolisib) is a kinase inhibitor indicated for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older.

RizaFilm (rizatriptan) Oral Film

Date of Approval: April 14, 2023
Company: IntelGenx Corp.
Treatment for: Migraine

RizaFilm (rizatriptan) is a serotonin (5-HT) 1B/1D receptor agonist (triptan) oral film formulation for the acute treatment of migraine.

Omisirge (omidubicel-onlv) Suspension for Infusion

Date of Approval: April 17, 2023
Company: Gamida Cell Ltd.
Treatment for: Stem Cell Therapy

Omisirge (omidubicel-onlv) is a nicotinamide (NAM) modified allogeneic hematopoietic progenitor cell therapy for use in patients with hematologic malignancies to reduce risk of infection following stem cell transplantation.

Qalsody (tofersen) Injection

Date of Approval: April 25, 2023
Company: Biogen Inc.
Treatment for: Amyotrophic Lateral Sclerosis

Qalsody (tofersen) is an antisense oligonucleotide indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.

Vowst (fecal microbiota spores, live-brpk) Capsules - formerly SER-109

Date of Approval: April 26, 2023
Company: Seres Therapeutics, Inc.
Treatment for: Prevention of Recurrent Clostridioides difficile Infection

Vowst (fecal microbiota spores, live-brpk) is an oral microbiome therapeutic indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI.

Uzedy (risperidone) Extended-Release Injectable Suspension

Date of Approval: April 28, 2023
Company: Teva Pharmaceuticals and MedinCell
Treatment for: Schizophrenia

Uzedy (risperidone) is a long-acting injectable atypical antipsychotic indicated for the treatment of schizophrenia in adults.

Abilify Asimtufii (aripiprazole) Extended-Release Injectable Suspension

Date of Approval: April 27, 2023
Company: Otsuka Pharmaceutical Co., Ltd.
Treatment for: Schizophrenia, Bipolar Disorder

Abilify Asimtufii (aripiprazole) is a long-acting injectable atypical antipsychotic for the treatment of schizophrenia and bipolar I disorder.

Lumryz (sodium oxybate) Granules for Extended-Release Oral Suspension

Date of Approval: May 1, 2023
Company: Avadel Pharmaceuticals plc
Treatment for: Narcolepsy

Lumryz (sodium oxybate) is a once-nightly formulation of the approved central nervous system depressant sodium oxybate indicated for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy.

Arexvy (respiratory syncytial virus vaccine, adjuvanted) Suspension for Intramuscular Injection

Date of Approval: May 3, 2023
Company: GlaxoSmithKline
Treatment for: Prevention of RSV Infection

Arexvy (respiratory syncytial virus vaccine, adjuvanted) is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in individuals 60 years of age and older.

Mydcombi (phenylephrine hydrochloride and tropicamide) Ophthalmic Spray

Date of Approval: May 5, 2023
Company: Eyenovia, Inc.
Treatment for: Pupillary Dilation

Mydcombi (phenylephrine hydrochloride and tropicamide) is an alpha-1 adrenergic receptor agonist and anticholinergic fixed-combination ophthalmic spray indicated to induce mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired.

Elfabrio (pegunigalsidase alfa-iwxj) Injection

Date of Approval: May 9, 2023
Company: Protalix BioTherapeutics, Inc.
Treatment for: Fabry Disease

Elfabrio (pegunigalsidase alfa-iwxj) is a hydrolytic lysosomal neutral glycosphingolipid-specific enzyme indicated for the treatment of adults with confirmed Fabry disease.

Veozah (fezolinetant) Tablets

Date of Approval: May 12, 2023
Company: Astellas Pharma Inc.
Treatment for: Menopausal Disorders, Hot Flashes

Veozah (fezolinetant) is a selective neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.

Skinvive by Juvederm (hyaluronic acid and lidocaine) Injectable Gel

Date of Approval: May 15, 2023
Company: Abbvie
Treatment for: Facial Wrinkles

Skinvive by Juvéderm (hyaluronic acid and lidocaine) is an intradermal microdroplet injection containing a dermal filler and a local anesthetic used to improve skin smoothness of the cheeks in adults over the age of 21.

Miebo (perfluorohexyloctane) Ophthalmic Solution - formerly NOV03

Date of Approval: May 18, 2023
Company: Bausch + Lomb Corporation and Novaliq
Treatment for: Dry Eye Disease

Miebo (perfluorohexyloctane) is a semifluorinated alkane indicated for treatment of the signs and symptoms of dry eye disease.

Vyjuvek (beremagene geperpavec-svdt) Topical Gel

Date of Approval: May 19, 2023
Company: Krystal Biotech, Inc.
Treatment for: Epidermolysis Bullosa

Vyjuvek (beremagene-geperpavec-svdt) is a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy for the treatment of wounds in patients dystrophic epidermolysis bullosa.

Epkinly (epcoritamab-bysp) Injection

Date of Approval: May 19, 2023
Company: AbbVie Inc.
Treatment for: Diffuse Large B-Cell Lymphoma

Epkinly (epcoritamab-bysp) is a bispecific CD20-directed CD3 T-cell engager for use in the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Opvee (nalmefene hydrochloride) Nasal Spray

Date of Approval: May 22, 2023
Company: Opiant Pharmaceuticals, Inc.
Treatment for: Opioid Overdose

Opvee (nalmefene hydrochloride) is a nasal spray formulation of the approved opioid antagonist nalmefene hydrochloride for use in the treatment of opioid overdose.

Brixadi (buprenorphine) Extended-Release Injection

Date of Approval: May 23, 2023
Company: Braeburn Inc.
Treatment for: Opioid Use Disorder

Brixadi (buprenorphine) is a partial opioid agonist for use in the treatment of opioid use disorder.

Xacduro (sulbactam and durlobactam (co-packaged)) Kit for Injection

Date of Approval: May 23, 2023
Company: Innoviva, Inc.
Treatment for: Acinetobacter Pneumonia

Xacduro (sulbactam and durlobactam) is a co-packaged product containing the beta-lactam antibacterial sulbactam, and the beta lactamase inhibitor durlobactam for use in the treatment of serious infections caused by Acinetobacter.

Yuflyma (adalimumab-aaty) Injection

Date of Approval: May 23, 2023
Company: Celltrion USA
Treatment for: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.

Yuflyma (adalimumab-aaty) is a tumor necrosis factor (TNF) blocker biosimilar to Humira, approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.

Paxlovid (nirmatrelvir and ritonavir) Tablets (co-packaged)

Date of Approval: May 25, 2023
Company: Pfizer Inc.
Treatment for: COVID-19

Paxlovid (nirmatrelvir and ritonavir) is a co-packaged product containing nirmatrelvir, a SARS-CoV-2 main protease inhibitor, and ritonavir, a HIV-1 protease inhibitor and CYP3A inhibitor, indicated for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.

Inpefa (sotagliflozin) Tablets

Date of Approval: May 26, 2023
Company: Lexicon Pharmaceuticals, Inc.
Treatment for: Heart Failure

Inpefa (sotagliflozin) is a sodium-glucose cotransporter 2 (SGLT2) inhibitor used in the treatment of heart failure.

Posluma (flotufolastat F 18) Injection

Date of Approval: May 25, 2023
Company: Blue Earth Diagnostics
Treatment for: Positron Emission Tomography Imaging, Diagnosis and Investigation

Posluma (flotufolastat F 18) a radioactive diagnostic agent used for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.

Abrysvo (respiratory syncytial virus vaccine) Injection

Date of Approval: May 31, 2023
Company: Pfizer, Inc.
Treatment for: RSV

Abrysvo (respiratory syncytial virus vaccine) is a vaccine used for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV).

Vevye (cyclosporine) Ophthalmic Solution - formerly CyclASol

Date of Approval: May 30, 2023
Company: Novaliq
Treatment for: Dry Eye Disease

Vevye (cyclosporine) is a calcineurin inhibitor immunosuppressant indicated for the treatment of the signs and symptoms of dry eye disease.

Columvi (glofitamab-gxbm) Injection

Date of Approval: June 15, 2023
Company: Genentech
Treatment for: Diffuse Large B-Cell Lymphoma

Columvi (glofitamab-gxbm) is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy.

Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) Injection

Date of Approval: June 20, 2023
Company: Halozyme Therapeutics, Inc.
Treatment for: Myasthenia Gravis

Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) is a neonatal Fc receptor blocker and endoglycosidase combination indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

Lodoco (colchicine) Tablets

Date of Approval: June 16, 2023
Company: AGEPHA Pharma USA, LLC
Treatment for: Cardiovascular Risk Reduction

Lodoco (colchicine) is an alkaloid indicated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease.

Liqrev (sildenafil citrate) Oral Suspension

Date of Approval: April 28, 2023
Company: CMP Pharma, Inc.
Treatment for: Pulmonary Arterial Hypertension

Liqrev (sildenafil citrate) is a ready-made oral liquid formulation of the approved phosphodiesterase-5 (PDE-5) inhibitor sildenafil used for the treatment of pulmonary arterial hypertension.

Suflave (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride) Powder for Oral Solution

Date of Approval: June 15, 2023
Company: Braintree Laboratories, Inc.
Treatment for: Bowel Preparation

Suflave (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride) is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults.

Elevidys (delandistrogene moxeparvovec-rokl) Suspension for Intravenous Infusion

Date of Approval: June 22, 2023
Company: Sarepta Therapeutics, Inc.
Treatment for: Duchenne Muscular Dystrophy

Elevidys (delandistrogene moxeparvovec-rokl) is an adeno-associated virus vector-based gene therapy indicated for the treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene.

Litfulo (ritlecitinib) Capsules

Date of Approval: June 23, 2023
Company: Pfizer Inc.
Treatment for: Alopecia

Litfulo (ritlecitinib) is a covalent kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older.

Rystiggo (rozanolixizumab-noli) Injection

Date of Approval: June 26, 2023
Company: UCB
Treatment for: Myasthenia Gravis

Rystiggo (rozanolixizumab-noli) is a neonatal Fc receptor blocker indicated for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor (AChR) or antimuscle-specific tyrosine kinase (MuSK) antibody positive.

Ngenla (somatrogon-ghla) Injection

Date of Approval: June 27, 2023
Company: Pfizer Inc.
Treatment for: Pediatric Growth Hormone Deficiency

Ngenla (somatrogon-ghla) is a long-acting human growth hormone analog used for the treatment of pediatric growth hormone deficiency.

Lantidra (donislecel-jujn) Cellular Suspension for Infusion

Date of Approval: June 28, 2023
Company: CellTrans, Inc.
Treatment for: Diabetes, Type 1

Lantidra (donislecel-jujn) is an allogeneic pancreatic islet cellular therapy for the treatment of type 1 diabetes mellitus in adults whose symptoms are not well controlled.

Roctavian (valoctocogene roxaparvovec-rvox) Suspension for Intravenous Infusion

Date of Approval: June 29, 2023
Company: BioMarin Pharmaceutical Inc.
Treatment for: Hemophilia A

Roctavian (valoctocogene-roxaparvovec-rvox) is an adeno-associated virus vector-based gene therapy for the treatment of adults with severe hemophilia A.

Opill (norgestrel) Tablets

Date of Approval: July 13, 2023
Company: Perrigo Company plc
Treatment for: Birth Control

Opill (norgestrel) is a progestin-only, over-the-counter birth control pill for the prevention of pregnancy.

Beyfortus (nirsevimab-alip) Injection

Date of Approval: July 17, 2023
Company: AstraZeneca
Treatment for: RSV

Beyfortus (nirsevimab-alip) is a respiratory syncytial virus (RSV) F protein-directed fusion inhibitor used for the prevention of RSV lower respiratory tract disease in neonates and infants.

Cyfendus (anthrax vaccine adsorbed, adjuvanted) Injection

Date of Approval: July 20, 2023
Company: Emergent BioSolutions Inc.
Treatment for: Anthrax Prophylaxis

Cyfendus (anthrax vaccine adsorbed, adjuvanted) is a vaccine indicated for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs.

Vanflyta (quizartinib) Tablets

Date of Approval: July 20, 2023
Company: Daiichi Sankyo
Treatment for: Acute Myeloid Leukemia

Vanflyta (quizartinib) is an oral FLT3-ITD (FMS-like tyrosine kinase-3-internal tandem duplication) inhibitor for the treatment of patients with FLT3-ITD positive acute myeloid leukemia.

Ycanth (cantharidin) Topical Solution - formerly VP-102

Date of Approval: July 21, 2023
Company: Verrica Pharmaceuticals Inc.
Treatment for: Molluscum Contagiosum

Ycanth (cantharidin) is a topical terpenoid for the treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older.

Xdemvy (lotilaner) Ophthalmic Solution - formerly TP-03

Date of Approval: July 25, 2023
Company: Tarsus Pharmaceuticals, Inc.
Treatment for: Demodex Blepharitis

Xdemvy (lotilaner ophthalmic solution) is an isoxazoline ectoparasiticide indicated for the treatment of Demodex blepharitis.

Balfaxar (prothrombin complex concentrate, human-lans) Lyophilized Powder for Injection

Date of Approval: July 21, 2023
Company: Octapharma USA, Inc.
Treatment for: Warfarin Reversal in Urgent Surgery & Invasive Procedures

Balfaxar (prothrombin complex concentrate, human-lans) is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for an urgent surgery/invasive procedure.

RiVive (naloxone hydrochloride) Nasal Spray

Date of Approval: July 28, 2023
Company: Harm Reduction Therapeutics, Inc.
Treatment for: Opioid Overdose

RiVive (naloxone hydrochloride) is an over-the-counter (OTC) opioid antagonist nasal spray indicated for the emergency treatment of opioid overdose.

Zurzuvae (zuranolone) Capsules

Date of Approval: August 4, 2023
Company: Sage Therapeutics, Inc.
Treatment for: Postpartum Depression

Zurzuvae (zuranolone) is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator indicated for the treatment of postpartum depression in adults.

Izervay (avacincaptad pegol) Intravitreal Solution

Date of Approval: August 4, 2023
Company: Iveric Bio, Inc.
Treatment for: Geographic Atrophy

Izervay (avacincaptad pegol) is a complement C5 protein inhibitor indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Talvey (talquetamab-tgvs) Injection

Date of Approval: August 9, 2023
Company: Janssen Pharmaceutical Companies of Johnson & Johnson
Treatment for: Multiple Myeloma

Talvey (talquetamab-tgvs) is a first-in-class, bispecific GPRC5D-directed CD3 T-cell engager for the treatment of patients with heavily pretreated multiple myeloma.

Akeega (abiraterone acetate and niraparib) Tablets

Date of Approval: August 11, 2023
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Prostate Cancer

Akeega (abiraterone acetate and niraparib) is a CYP17 inhibitor and a poly (ADP-ribose) polymerase (PARP) inhibitor combination indicated with prednisone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC).

Hepzato (melphalan) Lyophilized Powder for Injection

Date of Approval: August 14, 2023
Company: Delcath Systems, Inc.
Treatment for: Uveal Melanoma

Hepzato (melphalan) is an alkylating drug used as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases.

Elrexfio (elranatamab-bcmm) Injection

Date of Approval: August 14, 2023
Company: Pfizer Inc.
Treatment for: Multiple Myeloma

Elrexfio (elranatamab-bcmm) is a B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody (BsAb) for the treatment of patients with relapsed or refractory multiple myeloma.

Sohonos (palovarotene) Capsules

Date of Approval: August 16, 2023
Company: Ipsen
Treatment for: Fibrodysplasia Ossificans Progressiva

Sohonos (palovarotene) is a retinoid indicated for the reduction in volume of new heterotopic ossification in adults and pediatric patients aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP).

Veopoz (pozelimab-bbfg) Injection

Date of Approval: August 18, 2023
Company: Regeneron Pharmaceuticals, Inc.
Treatment for: CHAPLE Disease

Veopoz (pozelimab-bbfg) is a complement C5 inhibitor indicated for the treatment of adult and pediatric patients 1 year of age and older with CHAPLE disease.

Eylea HD (aflibercept) Injection

Date of Approval: August 18, 2023
Company: Regeneron Pharmaceuticals, Inc.
Treatment for: Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy

Eylea HD (aflibercept) is a higher dose formulation of the approved vascular endothelial growth factor (VEGF) inhibitor aflibercept indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (nAMD), diabetic macular edema (DME), and diabetic retinopathy (DR).

Tyruko (natalizumab-sztn) Injection

Date of Approval: August 24, 2023
Company: Sandoz Inc.
Treatment for: Multiple Sclerosis, Crohn's Disease

Tyruko (natalizumab-sztn) is an integrin receptor antagonist biosimilar to Tysabri, approved for the treatment of multiple sclerosis and Crohn’s disease.

Aphexda (motixafortide) Lyophilized Powder for Injection

Date of Approval: September 8, 2023
Company: BioLineRx Ltd.
Treatment for: Hematopoietic Stem Cell Mobilization

Aphexda (motixafortide) is a hematopoietic stem cell mobilizer indicated in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.

Ojjaara (momelotinib) Tablets

Date of Approval: September 15, 2023
Company: GSK
Treatment for: Myelofibrosis

Ojjaara (momelotinib) is a JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor for the treatment of myelofibrosis patients with anemia.

Likmez (metronidazole) Oral Suspension - formerly ATI-1501

Date of Approval: September 22, 2023
Company: Appili Therapeutics Inc. and Saptalis Pharmaceuticals , LLC
Treatment for: Bacterial Infection, Trichomoniasis, Amebiasis

Likmez (metronidazole) is an oral liquid suspension formulation of the approved nitroimidazole antimicrobial metronidazole for the treatment of trichomoniasis, amebiasis, and anaerobic bacterial infections.

Ryzumvi (phentolamine mesylate) Ophthalmic Solution - formerly Nyxol

Date of Approval: September 25, 2023
Company: Ocuphire Pharma, Inc.
Treatment for: Reversal of Pharmacologically Induced Mydriasis

Ryzumvi (phentolamine mesylate) is an alpha adrenergic blocker indicated for the treatment of pharmacologically-induced mydriasis.

Pombiliti (cipaglucosidase alfa-atga) Lyophilized Powder for Injection

Date of Approval: September 28, 2023
Company: Amicus Therapeutics
Treatment for: Pompe Disease

Pombiliti (cipaglucosidase alfa-atga) is a hydrolytic lysosomal glycogen-specific enzyme used in combination with Opfolda (miglustat) for the treatment of adults with late-onset Pompe disease.

Exxua (gepirone) Extended-Release Tablets

Date of Approval: September 22, 2023
Company: Fabre-Kramer Pharmaceuticals Inc.
Treatment for: Major Depressive Disorder

Exxua (gepirone) is an azapirone antidepressant for the treatment of adults with major depressive disorder.

Tofidence (tocilizumab-bavi) Injection

Date of Approval: September 29, 2023
Company: Biogen Inc.
Treatment for: Rheumatoid Arthritis, Polyarticular Juvenile Idiopathic Arthritis, Juvenile Idiopathic Arthritis

Tofidence (tocilizumab-bavi) is an interleukin-6 (IL-6) receptor antagonist biosimilar to Actemra indicated for treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.

Rivfloza (nedosiran) Injection

Date of Approval: September 29, 2023
Company: Novo Nordisk
Treatment for: Primary Hyperoxaluria

Rivfloza (nedosiran) is a lactate dehydrogenase A (LDHA) directed small interfering RNA used to lower urinary oxalate levels in patients with primary hyperoxaluria type 1 (PH1).

Technegas (technetium Tc 99m carbon) Inhalation Aerosol

Date of Approval: September 29, 2023
Company: Cyclopharm Limited
Treatment for: Diagnosis and Investigation

Technegas (technetium Tc 99m carbon) is a radioactive diagnostic agent for the evaluation of pulmonary embolism.

Velsipity (etrasimod) Tablets

Date of Approval: October 12, 2023
Company: Pfizer Inc.
Treatment for: Ulcerative Colitis

Velsipity (etrasimod) is a sphingosine-1-phosphate (S1P) receptor modulator indicated for the treatment of moderately-to-severely active ulcerative colitis (UC) in adults.

Zilbrysq (zilucoplan) Injection

Date of Approval: October 17, 2023
Company: UCB, Inc.

Zilbrysq (zilucoplan) is a peptide inhibitor of complement component 5 (C5 inhibitor) for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

Xphozah (tenapanor) Tablets

Date of Approval: October 17, 2023
Company: Ardelyx, Inc.
Treatment for: Hyperphosphatemia of Renal Failure

Xphozah (tenapanor) is a sodium hydrogen exchanger 3 (NHE3) inhibitor used to treat hyperphosphatemia in adults with chronic kidney disease.

Qlosi (pilocarpine hydrochloride) Ophthalmic Solution - formerly CSF-1

Date of Approval: October 17, 2023
Company: Orasis Pharmaceuticals
Treatment for: Presbyopia

Qlosi (pilocarpine hydrochloride ophthalmic solution) 0.4%, is a low dose formulation of the approved cholinergic agonist pilocarpine indicated for the treatment of presbyopia in adults.

Combogesic IV (acetaminophen and ibuprofen) Injection

Date of Approval: October 17, 2023
Company: AFT Pharmaceuticals Ltd.
Treatment for: Postoperative Pain

Combogesic IV (acetaminophen and ibuprofen) is an analgesic and nonsteroidal anti-inflammatory drug (NSAID) combination for the management of postoperative pain.

Bimzelx (bimekizumab-bkzx) Injection

Date of Approval: October 17, 2023
Company: UCB, Inc.
Treatment for: Plaque Psoriasis

Bimzelx (bimekizumab-bkzx) is a humanized interleukin-17A and interleukin-17F antagonist for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Penbraya (meningococcal groups A, B, C, W, and Y vaccine) Injection

Date of Approval: October 20, 2023
Company: Pfizer, Inc.
Treatment for: Meningococcal Disease Prophylaxis

Penbraya (meningococcal groups A, B, C, W, and Y vaccine) is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y in individuals 10 through 25 years of age.

Zituvio (sitagliptin) Tablets

Date of Approval: October 18, 2023
Company: Zydus Pharmaceuticals USA Inc.
Treatment for: Diabetes, Type 2

Zituvio (sitagliptin) is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Cabtreo (adapalene, benzoyl peroxide and clindamycin phosphate) Topical Gel

Date of Approval: October 20, 2023
Company: Bausch Health Companies Inc.
Treatment for: Acne

Cabtreo (adapalene, benzoyl peroxide and clindamycin phosphate) is a triple-combination for the topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older.

Zymfentra (infliximab-dyyb) Subcutaneous Injection

Date of Approval: October 20, 2023
Company: Celltrion USA
Treatment for: Crohn's Disease, Ulcerative Colitis

Zymfentra (infliximab-dyyb) is a tumor necrosis factor (TNF) blocker used for the maintenance treatment of ulcerative colitis and Crohn’s disease in adults.

Agamree (vamorolone) Oral Suspension

Date of Approval: October 26, 2023
Company: Catalyst Pharmaceuticals, Inc.
Treatment for: Duchenne Muscular Dystrophy

Agamree (vamorolone) is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy in patients 2 years of age and older.

Omvoh (mirikizumab-mrkz) Injection

Date of Approval: October 26, 2023
Company: Eli Lilly and Company
Treatment for: Ulcerative Colitis

Omvoh (mirikizumab-mrkz) is an interleukin-23 antagonist indicated for the treatment of moderately to severely active ulcerative colitis in adults.

Loqtorzi (toripalimab-tpzi) Injection

Date of Approval: October 27, 2023
Company: Coherus Biosciences, Inc.
Treatment for: Nasopharyngeal Carcinoma

Loqtorzi (toripalimab-tpzi) is a programmed death receptor-1 (PD-1)- blocking antibody used for the treatment of nasopharyngeal carcinoma.

Wezlana (ustekinumab-auub) Injection

Date of Approval: October 31, 2023
Company: Amgen, Inc.
Treatment for: Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, Ulcerative Colitis

Wezlana (ustekinumab-auub) is a human interleukin-12 and -23 antagonist interchangeable biosimilar to Stelara used for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

Voquezna (vonoprazan) Tablets

Date of Approval: November 1, 2023
Company: Phathom Pharmaceuticals, Inc.
Treatment for: Erosive Esophagitis

Voquezna (vonoprazan) is a potassium-competitive acid blocker (P-CAB) for the treatment of erosive esophagitis.

Zituvimet (metformin hydrochloride and sitagliptin) Tablets

Date of Approval: November 3, 2023
Company: Zydus Pharmaceuticals USA Inc.
Treatment for: Diabetes, Type 2

Zituvimet (metformin hydrochloride and sitagliptin) is a biguanide and dipeptidyl peptidase-4 (DPP-4) inhibitor combination indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Zepbound (tirzepatide) Injection

Date of Approval: November 8, 2023
Company: Eli Lilly and Company
Treatment for: Weight Loss (Obesity/Overweight)

Zepbound (tirzepatide) is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist used for chronic weight management in adults.

Fruzaqla (fruquintinib) Capsules

Date of Approval: November 8, 2023
Company: Takeda
Treatment for: Colorectal Cancer

Fruzaqla (fruquintinib) is a highly selective and potent oral inhibitor of VEGFR-1, -2 and -3 for the treatment of previously treated metastatic colorectal cancer.

Adzynma (ADAMTS13, recombinant-krhn) Lyophilized Powder for Injection

Date of Approval: November 9, 2023
Company: Takeda
Treatment for: Thrombotic Thrombocytopenic Purpura

Adzynma (ADAMTS13, recombinant-krhn) is a human recombinant “A disintegrin and metalloproteinase with thrombospondin motifs 13” (rADAMTS13) indicated for prophylactic or on demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura.

Ixchiq (chikungunya vaccine, live) Injection - formerly VLA1553

Date of Approval: November 9, 2023
Company: Valneva SE
Treatment for: Chikungunya Disease Prevention

Ixchiq (chikungunya vaccine, live) is a live-attenuated, single dose vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV.

DefenCath (taurolidine and heparin) Catheter Lock Solution

Date of Approval: November 15, 2023
Company: CorMedix Inc.
Treatment for: Prevention of Catheter-Related Bloodstream Infections

DefenCath (taurolidine and heparin) catheter lock solution is a thiadiazinane antimicrobial and anticoagulant combination indicated to reduce the incidence of catheter-related bloodstream infections in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC).

Augtyro (repotrectinib) Capsules

Date of Approval: November 15, 2023
Company: Bristol Myers Squibb
Treatment for: Non-Small Cell Lung Cancer

Augtyro (repotrectinib) is a tyrosine kinase inhibitor (TKI) for the treatment of patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

Truqap (capivasertib) Tablets

Date of Approval: November 16, 2023
Company: AstraZeneca
Treatment for: Breast Cancer

Truqap (capivasertib) is an AKT inhibitor used in combination with fulvestrant for the treatment of advanced hormone receptor-positive breast cancer.

Ryzneuta (efbemalenograstim alfa-vuxw) Injection

Date of Approval: November 16, 2023
Company: Evive Biotech
Treatment for: Neutropenia Associated with Chemotherapy

Ryzneuta (efbemalenograstim alfa-vuxw) is a leukocyte growth factor to used to reduce the duration of febrile neutropenia in patients treated with chemotherapy for certain types of cancer.

Ogsiveo (nirogacestat) Tablets

Date of Approval: November 27, 2023
Company: SpringWorks Therapeutics, Inc.
Treatment for: Desmoid Tumors

Ogsiveo (nirogacestat) is a gamma secretase inhibitor indicated for adult patients with progressing desmoid tumors who require systemic treatment.

Fabhalta (iptacopan) Capsules

Date of Approval: December 5, 2023
Company: Novartis
Treatment for: Paroxysmal Nocturnal Hemoglobinuria

Fabhalta (iptacopan) is a first-in-class, complement factor B inhibitor indicated for the treatment of adults with paroxysmal nocturnal hemoglobinuria.

Avzivi (bevacizumab-tnjn) Injection

Date of Approval: December 6, 2023
Company: Bio-Thera Solutions, Ltd.
Treatment for: Colorectal Cancer, Non-Small Cell Lung Cancer, Glioblastoma Multiforme, Renal Cell Carcinoma, Cervical Cancer, Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

Avzivi is a vascular endothelial growth factor inhibitor biosimilar to Avastin used for the treatment of colorectal cancer, non-small cell lung cancer, glioblastoma, renal cell carcinoma, cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Casgevy (exagamglogene autotemcel) Suspension for Intravenous Infusion

Date of Approval: December 8, 2023
Company: Vertex Pharmaceuticals Incorporated and CRISPR Therapeutics
Treatment for: Beta Thalassemia, Sickle Cell Disease

Casgevy (exagamglogene autotemcel) is a CRISPR/Cas9 genome-edited cell therapy for the treatment of sickle cell disease and transfusion-dependent beta-thalassemia.

Lyfgenia (lovotibeglogene autotemcel) Suspension for Intravenous Infusion

Date of Approval: December 8, 2023
Company: Bluebird Bio, Inc.
Treatment for: Sickle Cell Disease

Lyfgenia (lovotibeglogene autotemcel) is an autologous hematopoietic stem cell-based gene therapy indicated for the treatment of patients 12 years of age or older with sickle cell disease and a history of vaso-occlusive events.

iDose TR (travoprost) Intracameral Implant

Date of Approval: December 13, 2023
Company: Glaukos Corporation
Treatment for: Glaucoma, Open Angle, Glaucoma/Intraocular Hypertension

iDose TR (travoprost intracameral implant) is a long-duration prostaglandin analog indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Iwilfin (eflornithine) Tablets

Date of Approval: December 13, 2023
Company: US WorldMeds, LLC
Treatment for: Neuroblastoma

Iwilfin (eflornithine) is an ornithine decarboxylase inhibitor used to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB).

Alyglo (immune globulin intravenous, human-stwk) Liquid for Intravenous Injection

Date of Approval: December 15, 2023
Company: GC Biopharma USA, Inc.
Treatment for: Primary Immunodeficiency Syndrome

Alyglo (immune globulin intravenous, human-stwk) is a 10% immune globulin liquid for intravenous injection indicated for the treatment of primary humoral immunodeficiency (PI) in adults.

Filsuvez (birch triterpenes) Topical Gel - formerly Oleogel-S10

Date of Approval: December 19, 2023
Company: Chiesi Global Rare Diseases
Treatment for: Epidermolysis Bullosa

Filsuvez (birch triterpenes) is a topical birch bark extract indicated for the treatment of wounds associated with dystrophic epidermolysis bullosa and junctional epidermolysis bullosa in adult and pediatric patients 6 months of age and older.

Wainua (eplontersen) Injection

Date of Approval: December 21, 2023
Company: Ionis Pharmaceuticals and AstraZeneca
Treatment for: Hereditary Transthyretin-Mediated Amyloid Polyneuropathy (ATTRv-PN)

Wainua (eplontersen) is a transthyretin-directed antisense oligonucleotide indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.

New Drug Approvals Archive for 2023