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New Drug Approvals

The following drugs have recently been approved by the FDA. Includes newly approved drugs and new indications for drugs already approved.

See also: Generic approvals, Approval process, New indications & dosage forms

Joenja (leniolisib) Tablets

Company: Pharming Group N.V.
Date of Approval: March 24, 2023
Treatment for: Activated Phosphoinositide 3-Kinase 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.

Zynyz (retifanlimab-dlwr) Injection

Company: Incyte Corporation
Date of Approval: March 22, 2023
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

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

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

Daybue (trofinetide) Oral Solution

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

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

Zavzpret (zavegepant) Nasal Spray

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

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

Skyclarys (omaveloxolone) Capsules

Company: Reata Pharmaceuticals, Inc.
Date of Approval: February 28, 2023
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.

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

Company: Sanofi
Date of Approval: February 22, 2023
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.

Filspari (sparsentan) Tablets

Company: Travere Therapeutics, Inc.
Date of Approval: February 17, 2023
Treatment for: IgA 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

Company: Apellis Pharmaceuticals, Inc.
Date of Approval: February 17, 2023
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).

Lamzede (velmanase alfa-tycv) Lyophilized Powder for Injection

Company: Chiesi Global Rare Diseases
Date of Approval: February 16, 2023
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.

Jesduvroq (daprodustat) Tablets

Company: GlaxoSmithKline
Date of Approval: February 1, 2023
Treatment for: Anemia Associated with Chronic Renal Failure

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).

Jaypirca (pirtobrutinib) Tablets

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

Jaypirca (pirtobrutinib) is a non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor.

Orserdu (elacestrant) Tablets

Company: Menarini Group
Date of Approval: January 27, 2023
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.

Brenzavvy (bexagliflozin) Tablets

Company: TheracosBio, LLC
Date of Approval: January 20, 2023
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.

Rykindo (risperidone) for Extended-Release Injectable Suspension

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

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

Airsupra (albuterol and budesonide) Inhalation Aerosol

Company: AstraZeneca
Date of Approval: January 10, 2023
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.

Leqembi (lecanemab-irmb) Injection

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

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

Briumvi (ublituximab-xiiy) Injection

Company: TG Therapeutics, Inc.
Date of Approval: December 28, 2022
Treatment for: Multiple Sclerosis

Briumvi (ublituximab-xiiy) is a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease, in adults.

NexoBrid (anacaulase-bcdb) for Topical Gel

Company: MediWound Ltd.
Date of Approval: December 28, 2022
Treatment for: Thermal Burn

NexoBrid (anacaulase-bcdb) is a concentrate of proteolytic enzymes indicated for removal of eschar in adults with deep partial- and full-thickness thermal burns.

Xenoview (xenon Xe 129 hyperpolarized) for Oral Inhalation

Company: Polarean Imaging plc
Date of Approval: December 23, 2022
Treatment for: Diagnosis and Investigation, Imaging of Lung

Xenoview (xenon Xe 129 hyperpolarized) is a hyperpolarized contrast agent indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 12 years and older.

FDA drug approvals archive

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