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New Indications & Dosage Forms for Existing Drugs

Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens.

Iluvien (fluocinolone acetonide) Intravitreal Implant

New Indication Approved: March 12, 2025
Date of Original Approval: September 26, 2014

Iluvien (fluocinolone acetonide) is a corticosteroid implant for the treatment of diabetic macular edema and posterior uveitis.

Furoscix (furosemide) Injection

New Indication Approved: March 6, 2025
Date of Original Approval: October 7, 2022

Furoscix (furosemide) is a loop diuretic indicated for the at-home treatment of edema in adult patients with chronic heart failure or chronic kidney disease.

Neffy (epinephrine) Nasal Spray

Patient Population Altered: March 5, 2025
Date of Original Approval: August 9, 2024

neffy® (epinephrine) is an intranasal epinephrine formulation for the emergency treatment of allergic reactions.

Tevimbra (tislelizumab-jsgr) Injection

New Indication Approved: March 4, 2025
Date of Original Approval: March 13, 2024

Tevimbra (tislelizumab-jsgr) is a humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody for use in the treatment of esophageal cancer and gastric cancer.

TNKase (tenecteplase) Lyophilized Powder for Injection

New Indication Approved: February 28, 2025
Date of Original Approval: June 2, 2000

TNKase (tenecteplase) is a tissue plasminogen activator for use in the treatment of ischemic stroke and heart attack.

Odactra (house dust mite allergen extract) Sublingual Tablets

Patient Population Altered: February 27, 2025
Date of Original Approval: March 1, 2017

Odactra (house dust mite allergen extract) is a sublingual allergy immunotherapy (SLIT) tablet indicated as immunotherapy for house dust mite (HDM) allergies.

Sublocade (buprenorphine) Sustained-Release Injection

Labeling Revision Approved: February 21, 2025
Date of Original Approval: November 30, 2017

Sublocade (buprenorphine) is a once-monthly injectable partial opioid agonist formulation for the treatment of opioid use disorder (OUD).

Izervay (avacincaptad pegol) Intravitreal Solution

New Indication Approved: February 12, 2025
Date of Original Approval: August 4, 2023

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

Evrysdi (risdiplam) Powder for Oral Solution and Oral Tablets

New Dosage Form Approved: February 11, 2025
Date of Original Approval: August 7, 2020

Evrysdi (risdiplam) is a survival of motor neuron 2 (SMN2) splicing modifier indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.

Adcetris (brentuximab vedotin) Injection

New Indication Approved: February 11, 2025
Date of Original Approval: August 19, 2011

Adcetris (brentuximab vedotin) is a CD30-directed antibody-drug conjugate (ADC) used for the treatment of Hodgkin lymphoma, anaplastic large cell lymphoma, peripheral T-cell lymphoma, mycosis fungoides, and large B-cell lymphoma.

Susvimo (ranibizumab) Injection for Intravitreal Use via Ocular Implant

New Indication Approved: February 3, 2025
Date of Original Approval: October 25, 2021

Susvimo (ranibizumab) is a vascular endothelial growth factor (VEGF) inhibitor used for the treatment of neovascular (wet) age-related macular degeneration and diabetic macular edema.

Ozempic (semaglutide) Injection

New Indication Approved: January 28, 2025
Date of Original Approval: December 5, 2017

Ozempic (semaglutide) is a glucagon-like peptide-1 (GLP-1) analog for the treatment type 2 diabetes, to reduce the risk of major cardiovascular events in patients with type 2 diabetes and cardiovascular disease, and to reduce the risk of worsening kidney disease and cardiovascular death in patients with type 2 diabetes and chronic kidney disease.

Leqembi (lecanemab-irmb) Injection

New Dosage Regimen: January 27, 2025
Date of Original Approval: January 6, 2023

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

Enhertu (fam-trastuzumab deruxtecan-nxki) Injection

New Indication Approved: January 27, 2025
Date of Original Approval: December 20, 2019

Enhertu (fam-trastuzumab deruxtecan-nxki) is a HER2-directed antibody and topoisomerase inhibitor conjugate used for the treatment of HER2-positive breast cancer, HER2-low or HER2-ultralow breast cancer, HER2-mutant non-small cell lung cancer, HER2-positive gastric or gastroesophageal junction adenocarcinoma, and HER2-positive solid tumors.

Spravato (esketamine) Nasal Spray

New Indication Approved: January 17, 2025
Date of Original Approval: March 5, 2019

Spravato (esketamine) is a rapid acting, nasal spray formulation of a non-competitive N-methyl D-aspartate (NMDA) receptor antagonist for the treatment of treatment-resistant depression (TRD) and depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior.

Lumakras (sotorasib) Tablets

New Indication Approved: January 16, 2025
Date of Original Approval: May 28, 2021

Lumakras (sotorasib) is a KRAS G12C inhibitor used for the treatment of KRAS G12C-mutated non-small cell lung cancer and KRAS G12C-mutated colorectal cancer.

Calquence (acalabrutinib) Capsules and Tablets

New Indication Approved: January 16, 2025
Date of Original Approval: October 31, 2017

Calquence (acalabrutinib) is a highly selective, potent, Bruton tyrosine kinase (BTK) inhibitor for the treatment of mantle cell lymphoma, and chronic lymphocytic leukemia or small lymphocytic lymphoma.

Omvoh (mirikizumab-mrkz) Injection

New Indication Approved: January 15, 2025
Date of Original Approval: October 26, 2023

Omvoh (mirikizumab-mrkz) is an interleukin-23 antagonist used for the treatment of ulcerative colitis and Crohn’s disease.

Niktimvo (axatilimab-csfr) Injection

New Dosage Form Approved: January 15, 2025
Date of Original Approval: August 14, 2024

Niktimvo (axatilimab-csfr) is a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody used for the treatment of chronic graft-versus-host disease.

Tevimbra (tislelizumab-jsgr) Injection

New Indication Approved: December 26, 2024
Date of Original Approval: March 13, 2024

Tevimbra (tislelizumab-jsgr) is a humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody for use in the treatment of esophageal cancer and gastric cancer.

Zepbound (tirzepatide) Injection

New Indication Approved: December 20, 2024
Date of Original Approval: November 8, 2023

Zepbound (tirzepatide) is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist used for weight reduction in adults with obesity or adults with overweight, and severe obstructive sleep apnea in adults with obesity.

Braftovi (encorafenib) Capsules

New Indication Approved: December 20, 2024
Date of Original Approval: June 27, 2018

Braftovi (encorafenib) is a kinase inhibitor used for the treatment of melanoma, colorectal cancer, and non-small cell lung cancer with BRAF mutations.

Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) Tablets and Oral Granules

Labeling Revision Approved: December 20, 2024
Date of Original Approval: October 21, 2019

Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is a triple combination regimen for the treatment of cystic fibrosis (CF) in patients ages 2 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive to Trikafta based on in vitro data.

Imcivree (setmelanotide) Injection

Patient Population Altered: December 20, 2024
Date of Original Approval: November 25, 2020

Imcivree (setmelanotide) is a melanocortin-4 receptor agonist used for weight management in patients with rare, genetic diseases of obesity.

Gemtesa (vibegron) Tablets

New Indication Approved: December 18, 2024
Date of Original Approval: December 23, 2020

Gemtesa (vibegron) is a once-daily beta-3 adrenergic agonist for use in the treatment of overactive bladder.

Nemluvio (nemolizumab) for Injection

New Indication Approved: December 13, 2024
Date of Original Approval: August 12, 2024

Nemluvio (nemolizumab) is an interleukin-31 receptor antagonist indicated for the treatment of prurigo nodularis and atopic dermatitis.

Vtama (tapinarof) Cream

New Indication Approved: December 12, 2024
Date of Original Approval: May 23, 2022

Vtama (tapinarof) is a topical aryl hydrocarbon receptor (AhR) modulating agent used for the treatment of plaque psoriasis and atopic dermatitis.

Imfinzi (durvalumab) Injection

New Indication Approved: December 4, 2024
Date of Original Approval: May 1, 2017

Imfinzi (durvalumab) is a programmed death-ligand 1 (PD-L1) blocking antibody used for the treatment of non-small cell lung cancer, small cell lung cancer, biliary tract cancer, hepatocellular carcinoma, and endometrial cancer.

Acetadote (acetylcysteine) Injection

New Dosage Regimen: November 26, 2024
Date of Original Approval: January 23, 2004

Acetadote (acetylcysteine) is an antidote used to prevent or lessen potential liver damage resulting from acetaminophen overdose.

Bimzelx (bimekizumab-bkzx) Injection

New Indication Approved: November 20, 2024
Date of Original Approval: October 17, 2023

Bimzelx (bimekizumab-bkzx) is a humanized interleukin-17A and interleukin-17F antagonist for the treatment of plaque psoriasis, psoriatic arthritis, non-radiographic axial spondyloarthritis, ankylosing spondylitis, and hidradenitis suppurativa.

Scemblix (asciminib) Tablets

New Indication Approved: October 29, 2024
Date of Original Approval: October 29, 2021

Scemblix (asciminib) is a tyrosine kinase inhibitor used for the treatment of patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML).

RoxyBond (oxycodone hydrochloride) Tablets

New Dosage Form Approved: October 29, 2024
Date of Original Approval: April 20, 2017

RoxyBond (oxycodone hydrochloride) is an immediate-release, abuse-deterrent, narcotic analgesic formulation for the management of severe pain.

Jylamvo (methotrexate) Oral Solution

New Indication Approved: October 29, 2024
Date of Original Approval: November 29, 2022

Jylamvo (methotrexate) is a folate analog metabolic inhibitor used for the treatment of acute lymphoblastic leukemia, mycosis fungoides, non-Hodgkin lymphoma, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and psoriasis.

Abrysvo (respiratory syncytial virus vaccine) Injection

Patient Population Altered: October 22, 2024
Date of Original Approval: May 31, 2023

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

Botox Cosmetic (onabotulinumtoxinA) for Injection

New Indication Approved: October 18, 2024
Date of Original Approval: April 12, 2002

Botox Cosmetic (onabotulinumtoxinA) is an acetylcholine release inhibitor and a neuromuscular blocking agent used for temporary improvement in the appearance of glabellar lines, lateral canthal lines, forehead lines, and platysma bands.

Selarsdi (ustekinumab-aekn) Injection

New Indication Approved: October 18, 2024
Date of Original Approval: April 16, 2024

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

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

Patient Population Altered: October 16, 2024
Date of Original Approval: May 1, 2023

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 patients 7 years of age and older with narcolepsy.

Bimzelx (bimekizumab-bkzx) Injection

New Dosage Form Approved: October 11, 2024
Date of Original Approval: October 17, 2023

Bimzelx (bimekizumab-bkzx) is a humanized interleukin-17A and interleukin-17F antagonist for the treatment of plaque psoriasis, psoriatic arthritis, non-radiographic axial spondyloarthritis, ankylosing spondylitis, and hidradenitis suppurativa.

Ameluz (aminolevulinic acid) Gel

New Dosage Regimen: October 4, 2024
Date of Original Approval: May 10, 2016

Ameluz (aminolevulinic acid) is a porphyrin precursor used in combination with the BF-RhodoLED lamp for photodynamic therapy (PDT) treatment of actinic keratoses on the face and scalp.

Opdivo (nivolumab) Injection

New Indication Approved: October 3, 2024
Date of Original Approval: December 22, 2014

Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of melanoma, non-small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, MSI-H or dMMR metastatic colorectal cancer, hepatocellular carcinoma, esophageal cancer, gastric cancer, and gastroesophageal junction cancer.

Dupixent (dupilumab) Injection

New Indication Approved: September 27, 2024
Date of Original Approval: March 28, 2017

Dupixent (dupilumab) is an interleukin-4 receptor alpha antagonist used for the treatment of atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, prurigo nodularis, and chronic obstructive pulmonary disease (COPD).

Retevmo (selpercatinib) Capsules and Tablets

Labeling Revision Approved: September 27, 2024
Date of Original Approval: May 8, 2020

Retevmo (selpercatinib) is a kinase inhibitor used for the treatment of certain cancers caused by abnormal RET genes.

Tagrisso (osimertinib) Tablets

New Indication Approved: September 25, 2024
Date of Original Approval: November 13, 2015

Tagrisso (osimertinib) is a tyrosine kinase inhibitor used for the treatment of epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).

Bimzelx (bimekizumab-bkzx) Injection

New Indication Approved: September 20, 2024
Date of Original Approval: October 17, 2023

Bimzelx (bimekizumab-bkzx) is a humanized interleukin-17A and interleukin-17F antagonist for the treatment of plaque psoriasis, psoriatic arthritis, non-radiographic axial spondyloarthritis, ankylosing spondylitis, and hidradenitis suppurativa.

Sarclisa (isatuximab-irfc) Injection

New Indication Approved: September 20, 2024
Date of Original Approval: March 2, 2020

Sarclisa (isatuximab-irfc) is a CD38-directed cytolytic antibody used for the treatment of multiple myeloma.

FluMist (Influenza Virus Vaccine, Live, Intranasal) Nasal Spray

New Dosage Regimen: September 20, 2024
Date of Original Approval: June 17, 2003

FluMist (influenza virus vaccine, live, intranasal) is a nasally administered vaccine intended for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

Rybrevant (amivantamab-vmjw) Injection

New Indication Approved: September 19, 2024
Date of Original Approval: May 21, 2021

Rybrevant (amivantamab-vmjw) is a bispecific EGF receptor-directed and MET receptor-directed antibody used for the treatment of EGFR mutated non-small cell lung cancer.

Fasenra (benralizumab) Injection

New Indication Approved: September 17, 2024
Date of Original Approval: November 14, 2017

Fasenra (benralizumab) is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody used for the treatment of eosinophilic asthma and eosinophilic granulomatosis with polyangiitis.

Kisqali (ribociclib) Tablets

New Indication Approved: September 17, 2024
Date of Original Approval: March 13, 2017

Kisqali (ribociclib) is an inhibitor of cyclin-dependent kinase (CDK) 4 and 6 used for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

Keytruda (pembrolizumab) for Injection

New Indication Approved: September 17, 2024
Date of Original Approval: September 4, 2014

Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody indicated for the treatment of melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) cancer, microsatellite instability-high or mismatch repair deficient colorectal cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, biliary tract cancer, Merkel cell carcinoma, renal cell carcinoma, endometrial carcinoma, tumor mutational burden-high (TMB-H) cancer, cutaneous squamous cell carcinoma, triple-negative breast cancer, and malignant pleural mesothelioma.

See also: New Drug Approvals, New Drug Applications, Recent Additions to Drugs.com

New indications and dosage forms archive