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

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.

• FDA Approves Tyruko (natalizumab-sztn), a Biosimilar to Tysabri – August 24, 2023
• Tyruko FDA Approval History

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.

• FDA Approves Veopoz (pozelimab-bbfg) as the First Treatment for Children and Adults with CHAPLE Disease – August 18, 2023
• Veopoz FDA Approval History

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).

• FDA Approves Eylea HD (aflibercept) Injection 8 mg for Treatment of Wet Age-related Macular Degeneration (wAMD), Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR) – August 18, 2023
• Eylea HD FDA Approval History

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).

• FDA Approves Sohonos (palovarotene) for the Treatment of Fibrodysplasia Ossificans Progressiva – August 16, 2023
• Sohonos FDA Approval History

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.

• FDA Grants Accelerated Approval for Elrexfio (elranatamab-bcmm) for Relapsed or Refractory Multiple Myeloma – August 14, 2023
• Elrexfio FDA Approval History

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.

• FDA Approves Hepzato Kit (melphalan) Hepatic Delivery System for the Treatment of Unresectable Hepatic-Dominant Metastatic Uveal Melanoma – August 14, 2023
• Hepzato FDA Approval History

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).

• FDA Approves Akeega (niraparib and abiraterone acetate) for the Treatment of Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer – August 11, 2023
• Akeega FDA Approval History

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.

• FDA Approves Talvey (talquetamab-tgvs), a First-in-Class Bispecific Therapy for the Treatment of Patients with Heavily Pretreated Multiple Myeloma – August 10, 2023
• Talvey FDA Approval History

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.

• FDA Approves Zurzuvae (zuranolone) First Oral Treatment for Postpartum Depression – August 4, 2023
• Zurzuvae FDA Approval History

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).

• FDA Approves Izervay (avacincaptad pegol) Intravitreal Solution for the Treatment for Geographic Atrophy – August 5, 2023
• Izervay FDA Approval History

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.

• FDA Approves RiVive (naloxone hydrochloride) Over-the-Counter Nasal Spray for the Emergency Treatment of Opioid Overdose – July 28, 2023
• RiVive FDA Approval History

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.

• FDA Approves Xdemvy (lotilaner) Ophthalmic Solution for the Treatment of Demodex Blepharitis – July 25, 2023
• Xdemvy FDA Approval History

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.

• FDA Approves Ycanth (cantharidin) Topical Solution for the Treatment of Molluscum Contagiosum – July 21, 2023
• Ycanth FDA Approval History

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.

• FDA Approves Balfaxar (prothrombin complex concentrate, human-lans) for Warfarin Reversal in Urgent Surgery & Invasive Procedures – July 26, 2023
• Balfaxar FDA Approval History

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.

• FDA Approves Vanflyta (quizartinib) for Patients with Newly Diagnosed FLT3-ITD Positive Acute Myeloid Leukemia – July 20, 2023
• Vanflyta FDA Approval History

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.

• FDA Approves Cyfendus (Anthrax Vaccine Adsorbed, Adjuvanted) Two-Dose Anthrax Vaccine for Post-Exposure Prophylaxis Use – July 20, 2023
• Cyfendus FDA Approval History

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.

• FDA Approves Beyfortus (nirsevimab) for the Prevention of RSV Lower Respiratory Tract Disease in Infants – July 17, 2023
• Beyfortus FDA Approval History

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.

• FDA Approves Opill (norgestrel) OTC Daily Oral Contraceptive – July 13, 2023
• Opill FDA Approval History

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.

• FDA Approves Roctavian (valoctocogene roxaparvovec-rvox) Gene Therapy for Adults with Severe Hemophilia A – June 29, 2023
• Roctavian FDA Approval History

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 Approves Lantidra (donislecel-jujn) Cellular Therapy to Treat Patients with Type 1 Diabetes – June 28, 2023
• Lantidra FDA Approval History

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