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New Drug Approvals Archive for 2024

See also: New Indications and Dosage Forms for 2024

Zelsuvmi (berdazimer sodium) Topical Gel

Date of Approval: January 5, 2024
Company: Ligand Pharmaceuticals Incorporated
Treatment for: Molluscum Contagiosum

Zelsuvmi (berdazimer sodium) is a nitric oxide-releasing agent indicated for the topical treatment of molluscum contagiosum (MC) in adults and pediatric patients 1 year of age and older.

Eohilia (budesonide) Oral Suspension - formerly TAK-721

Date of Approval: February 9, 2024
Company: Takeda Pharmaceutical Company Limited
Treatment for: Eosinophilic Esophagitis

Eohilia (budesonide oral suspension) is a mucoadherent formulation of the approved corticosteroid budesonide used for the treatment of eosinophilic esophagitis.

Aurlumyn (iloprost) Injection

Date of Approval: February 13, 2024
Company: Eicos Sciences Inc.
Treatment for: Frostbite

Aurlumyn (iloprost) is a prostacyclin mimetic indicated for the treatment of severe frostbite in adults to reduce the risk of digit amputations.

Amtagvi (lifileucel) Suspension for Intravenous Infusion

Date of Approval: February 16, 2024
Company: Iovance Biotherapeutics, Inc.
Treatment for: Melanoma

Amtagvi (lifileucel) is a tumor-derived autologous T cell immunotherapy used for the treatment of adult patients with unresectable or metastatic melanoma.

Simlandi (adalimumab-ryvk) Injection

Date of Approval: February 23, 2024
Company: Alvotech and Teva Pharmaceutical Industries Ltd.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa, Uveitis

Simlandi (adalimumab-ryvk) is a tumor necrosis factor (TNF) blocker interchangeable 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.

Exblifep (cefepime and enmetazobactam) Injection

Date of Approval: February 22, 2024
Company: Allecra Therapeutics
Treatment for: Urinary Tract Infection

Exblifep (cefepime and enmetazobactam) is a fourth generation cephalosporin and beta lactamase inhibitor combination for the treatment of complicated urinary tract infections (cUTIs).

Letybo (letibotulinumtoxinA-wlbg) Powder for Injection

Date of Approval: February 29, 2024
Company: Hugel, Inc.
Treatment for: Glabellar Lines

Letybo (letibotulinumtoxinA-wlbg) is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.

Jubbonti (denosumab-bbdz) Injection

Date of Approval: March 5, 2024
Company: Sandoz
Treatment for: Osteoporosis

Jubbonti (denosumab-bbdz) is a RANK ligand (RANKL) inhibitor interchangeable biosimilar to Prolia (denosumab) used in the treatment of osteoporosis.

Wyost (denosumab-bbdz) Injection

Date of Approval: March 5, 2024
Company: Sandoz
Treatment for: Osteolytic Bone Lesions of Multiple Myeloma, Osteolytic Bone Metastases of Solid Tumors, Giant Cell Tumor of Bone, Hypercalcemia of Malignancy

Wyost (denosumab-bbdz) is a RANK ligand (RANKL) inhibitor interchangeable biosimilar to Xgeva (denosumab) indicated for the prevention of skeletal-related events in patients with multiple myeloma or bone metastases from solid tumors, treatment of giant cell tumor of bone, and treatment of hypercalcemia of malignancy.

Tyenne (tocilizumab-aazg) Injection

Date of Approval: March 5, 2024
Company: Fresenius Kabi
Treatment for: Rheumatoid Arthritis, Giant Cell Arteritis, Polyarticular Juvenile Idiopathic Arthritis, Juvenile Idiopathic Arthritis

Tyenne (tocilizumab-aazg) is an interleukin-6 (IL-6) receptor antagonist biosimilar to Actemra used for treatment of rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.

Tevimbra (tislelizumab-jsgr) Injection

Date of Approval: March 13, 2024
Company: BeiGene, Ltd.
Treatment for: Esophageal Carcinoma

Tevimbra (tislelizumab-jsgr) is a humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody indicated for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor .

Rezdiffra (resmetirom) Tablets

Date of Approval: March 14, 2024
Company: Madrigal Pharmaceuticals, Inc.
Treatment for: Nonalcoholic Steatohepatitis

Rezdiffra (resmetirom) is a thyroid hormone receptor-beta (THR-beta) agonist indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis).

Lenmeldy (atidarsagene autotemcel) Suspension for Intravenous Infusion - formerly OTL-200

Date of Approval: March 18, 2024
Company: Orchard Therapeutics
Treatment for: Metachromatic Leukodystrophy

Lenmeldy (atidarsagene autotemcel) is an autologous hematopoietic stem cell (HSC) gene therapy for the treatment of children with metachromatic leukodystrophy (MLD).

Tryvio (aprocitentan) Tablets

Date of Approval: March 19, 2024
Company: Idorsia Ltd.
Treatment for: High Blood Pressure

Tryvio (aprocitentan) is an endothelin receptor antagonist (ERA) for the combination treatment of hypertension that is not adequately controlled with other drugs.

Opsynvi (macitentan and tadalafil) Tablets

Date of Approval: March 22, 2024
Company: Actelion Pharmaceuticals US, Inc.
Treatment for: Pulmonary Arterial Hypertension

Opsynvi (macitentan and tadalafil) is an endothelin receptor antagonist (ERA) and phosphodiesterase 5 (PDE5) inhibitor combination for the treatment of pulmonary arterial hypertension.

Duvyzat (givinostat) Oral Suspension

Date of Approval: March 21, 2024
Company: Italfarmaco Group
Treatment for: Duchenne Muscular Dystrophy

Duvyzat (givinostat) is a histone deacetylase inhibitor indicated for the treatment of Duchenne muscular dystrophy in patients 6 years of age and older.

Winrevair (sotatercept) for Injection

Date of Approval: March 26, 2024
Company: Merck
Treatment for: Pulmonary Arterial Hypertension

Winrevair (sotatercept) is an activin signaling inhibitor used for the treatment of adults with pulmonary arterial hypertension.

Vafseo (vadadustat) Tablets

Date of Approval: March 27, 2024
Company: Akebia Therapeutics, Inc.
Treatment for: Anemia Due to Chronic Kidney Disease

Vafseo (vadadustat) is a hypoxia-inducible factor prolyl hydroxylase (HIF PH) inhibitor indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months.

Voydeya (danicopan) Tablets

Date of Approval: March 29, 2024
Company: AstraZeneca
Treatment for: Paroxysmal Nocturnal Hemoglobinuria

Voydeya (danicopan) is a complement factor D inhibitor used for the treatment of extravascular hemolysis in adults with paroxysmal nocturnal hemoglobinuria.

Risvan (risperidone) for Extended-Release Injectable Suspension

Date of Approval: March 29, 2024
Company: Laboratorios Farmacéuticos Rovi, S.A.
Treatment for: Schizophrenia

Risvan (risperidone) is an atypical antipsychotic indicated for the treatment of schizophrenia in adults.

Zevtera (ceftobiprole medocaril) for Injection

Date of Approval: April 3, 2024
Company: Basilea Pharmaceutica Ltd.
Treatment for: Bacteremia, Skin and Structure Infection, Pneumonia

Zevtera (ceftobiprole medocaril) is a cephalosporin antibiotic for the treatment of bacteremia, acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia.

Xromi (hydroxyurea) Oral Solution

Date of Approval: April 4, 2024
Company: Nova Laboratories, Ltd.
Treatment for: Sickle Cell Anemia

Xromi (hydroxyurea) is an antimetabolite indicated to reduce the frequency of painful crises and reduce the need for blood transfusions in pediatric patients aged 6 months of age to less than 2 years with sickle cell anemia with recurrent moderate to severe painful crises.

Selarsdi (ustekinumab-aekn) Injection

Date of Approval: April 16, 2024
Company: Alvotech and Teva Pharmaceuticals
Treatment for: Plaque Psoriasis, Psoriatic Arthritis

Selarsdi (ustekinumab-aekn) is a human interleukin-12 and -23 antagonist biosimilar to Stelara used for the treatment of plaque psoriasis and psoriatic arthritis.

Lumisight (pegulicianine) for Injection

Date of Approval: April 17, 2024
Company: Lumicell, Inc.
Treatment for: Diagnosis and Investigation

Lumisight (pegulicianine) is an optical imaging agent for the detection of residual cancerous tissue during breast cancer surgery.

Rezenopy (naloxone hydrochloride) Nasal Spray

Date of Approval: April 19, 2024
Company: Summit Biosciences Inc.
Treatment for: Opioid Overdose

Rezenopy (naloxone hydrochloride) nasal spray is an opioid antagonist for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression in adult and pediatric patients.

Anktiva (nogapendekin alfa inbakicept-pmln) - formerly N-803

Date of Approval: April 22, 2024
Company: ImmunityBio, Inc.
Treatment for: Bladder Cancer

Anktiva (nogapendekin alfa inbakicept-pmln) is a first-in-class interleukin-15 superagonist for use in combination with Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle-invasive bladder cancer carcinoma.

Ojemda (tovorafenib) Tablets and Oral Suspension

Date of Approval: April 23, 2024
Company: Day One Biopharmaceuticals, Inc.
Treatment for: Low-Grade Glioma

Ojemda (tovorafenib) is a type II pan-RAF kinase inhibitor for the treatment of pediatric low-grade glioma.

Pivya (pivmecillinam) Tablets

Date of Approval: April 24, 2024
Company: Utility Therapeutics Ltd.
Treatment for: Urinary Tract Infection

Pivya (pivmecillinam) is a penicillin class antibacterial for use in the treatment of uncomplicated urinary tract infections.

Beqvez (fidanacogene elaparvovec-dzkt) Injection

Date of Approval: April 26, 2024
Company: Pfizer Inc.
Treatment for: Hemophilia B

Beqvez (fidanacogene elaparvovec-dzkt) is an adeno-associated virus vector-based gene therapy for the treatment of adults with moderate to severe hemophilia B (congenital factor IX deficiency).

Hercessi (trastuzumab-strf) for Injection

Date of Approval: April 25, 2024
Company: Accord BioPharma, Inc.
Treatment for: Breast Cancer, Gastric or Gastroesophageal Junction Adenocarcinoma

Hercessi (trastuzumab-strf) is a HER2/neu receptor antagonist biosimilar to Herceptin indicated for the treatment of HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinoma.

Xolremdi (mavorixafor) Capsules

Date of Approval: April 26, 2024
Company: X4 Pharmaceuticals
Treatment for: WHIM Syndrome

Xolremdi (mavorixafor) is a CXC chemokine receptor 4 (CXCR4) antagonist indicated in patients 12 years of age and older with WHIM syndrome to increase the number of circulating mature neutrophils and lymphocytes.

Libervant (diazepam) Buccal Film

Date of Approval: April 26, 2024
Company: Aquestive Therapeutics, Inc.
Treatment for: Seizure Clusters

Libervant (diazepam) is a buccal film formulation of the benzodiazepine diazepam that may be given to treat children aged 2 to 5 years with seizure clusters (also known as “acute repetitive seizures”) that are different from their usual seizure pattern.

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