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 approvalsApproval processNew indications & dosage forms

Tyruko (natalizumab-sztn) Injection

Company: Sandoz Inc.
Date of Approval: August 24, 2023
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.

Veopoz (pozelimab-bbfg) Injection

Company: Regeneron Pharmaceuticals, Inc.
Date of Approval: August 18, 2023
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

Company: Regeneron Pharmaceuticals, Inc.
Date of Approval: August 18, 2023
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).

Sohonos (palovarotene) Capsules

Company: Ipsen Biopharmaceuticals, Inc.
Date of Approval: August 16, 2023
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).

Elrexfio (elranatamab-bcmm) Injection

Company: Pfizer Inc.
Date of Approval: August 14, 2023
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.

Hepzato (melphalan) Lyophilized Powder for Injection

Company: Delcath Systems, Inc.
Date of Approval: August 14, 2023
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.

Akeega (abiraterone acetate and niraparib) Tablets

Company: Janssen Pharmaceuticals, Inc.
Date of Approval: August 11, 2023
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).

Talvey (talquetamab-tgvs) Injection

Company: Janssen Pharmaceuticals, Inc.
Date of Approval: August 9, 2023
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.

Zurzuvae (zuranolone) Capsules

Company: Sage Therapeutics, Inc.
Date of Approval: August 4, 2023
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

Company: Iveric Bio, Inc.
Date of Approval: August 4, 2023
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).

RiVive (naloxone hydrochloride) Nasal Spray

Company: Harm Reduction Therapeutics, Inc.
Date of Approval: July 28, 2023
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.

Xdemvy (lotilaner) Ophthalmic Solution – formerly TP-03

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

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

Ycanth (cantharidin) Topical Solution – formerly VP-102

Company: Verrica Pharmaceuticals Inc.
Date of Approval: July 21, 2023
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.

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

Company: Octapharma USA, Inc.
Date of Approval: July 21, 2023
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.

Vanflyta (quizartinib) Tablets

Company: Daiichi Sankyo Inc.
Date of Approval: July 20, 2023
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.

Cyfendus (anthrax vaccine adsorbed, adjuvanted) Injection

Company: Emergent BioSolutions Inc.
Date of Approval: July 20, 2023
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.

Beyfortus (nirsevimab-alip) Injection

Company: AstraZeneca
Date of Approval: July 17, 2023
Treatment for: Respiratory Syncytial Virus

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.

Opill (norgestrel) Tablets

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

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

Roctavian (valoctocogene roxaparvovec-rvox) Suspension for Intravenous Infusion

Company: BioMarin Pharmaceutical Inc.
Date of Approval: June 29, 2023
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.

Lantidra (donislecel-jujn) Cellular Suspension for Infusion

Company: CellTrans, Inc.
Date of Approval: June 28, 2023
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.

FDA drug approvals archive


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