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.
Ingrezza (valbenazine) Capsules
New Formulation Approved: April 30, 2024
Date of Original Approval: April 11, 2017
Ingrezza (valbenazine) is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of tardive dyskinesia and chorea associated with Huntington’s disease.
Cyltezo (adalimumab-adbm) Injection
New Formulation Approved: April 30, 2024
Date of Original Approval: August 25, 2017
Cyltezo (adalimumab-adbm) is an anti-TNF-α monoclonal antibody 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.
Tivdak (tisotumab vedotin-tftv) Lyophilized Powder for Injection
Labeling Revision Approved: April 29, 2024
Date of Original Approval: September 20, 2021
Tivdak (tisotumab vedotin-tftv) is a tissue factor-directed antibody and microtubule inhibitor conjugate for the treatment of patients with recurrent or metastatic cervical cancer.
Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide) Tablets
Labeling Revision Approved: April 24, 2024
Date of Original Approval: February 7, 2018
Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide) is a combination of an integrase strand transfer inhibitor (bictegravir) and two HIV-1 nucleoside analog reverse transcriptase inhibitors (emtricitabine and tenofovir alafenamide) used for the treatment of HIV-1 infection.
Lutathera (lutetium Lu 177 dotatate) Injection
Patient Population Altered: April 23, 2024
Date of Original Approval: January 26, 2018
Lutathera (lutetium Lu 177 dotatate) is a Lu-177-labeled somatostatin analogue indicated for the treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.
Lumify (brimonidine tartrate) Ophthalmic Solution
New Formulation Approved: April 19, 2024
Date of Original Approval: December 22, 2017
Lumify (brimonidine tartrate) is an over-the-counter (OTC) formulation of the alpha-adrenergic agonist brimonidine indicated for use in the treatment of ocular redness.
Entyvio (vedolizumab) Injection
New Dosage Regimen: April 18, 2024
Date of Original Approval: May 20, 2014
Entyvio (vedolizumab) is an integrin receptor antagonist for the treatment of Crohn's disease and ulcerative colitis.
Alecensa (alectinib) Capsules
New Indication Approved: April 18, 2024
Date of Original Approval: December 11, 2015
Alecensa (alectinib) is an anaplastic lymphoma kinase (ALK) inhibitor for the treatment of ALK-positive non-small cell lung cancer.
Enhertu (fam-trastuzumab deruxtecan-nxki) Injection
New Indication Approved: April 5, 2024
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 breast cancer, HER2-mutant non-small cell lung cancer, HER2-positive gastric or gastroesophageal junction adenocarcinoma, and HER2-positive solid tumors.
Carvykti (ciltacabtagene autoleucel) Suspension for Intravenous Infusion
New Indication Approved: April 5, 2024
Date of Original Approval: February 28, 2022
Carvykti (ciltacabtagene autoleucel) is a BCMA-directed CAR-T immunotherapy for the treatment of patients with relapsed or refractory multiple myeloma.
Dovato (dolutegravir and lamivudine) Tablets
Patient Population Altered: April 5, 2024
Date of Original Approval: April 8, 2019
Dovato (dolutegravir and lamivudine) is an integrase strand transfer inhibitor and nucleoside analogue reverse transcriptase inhibitor combination used for the treatment of HIV-1 infection.
Fasenra (benralizumab) Injection
Patient Population Altered: April 5, 2024
Date of Original Approval: November 14, 2017
Fasenra (benralizumab) is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody indicated for the treatment of patients with severe eosinophilic asthma.
Xcopri (cenobamate) Tablets
New Dosage Regimen: April 5, 2024
Date of Original Approval: November 21, 2019
Xcopri (cenobamate) is an antiepileptic drug for the treatment of partial-onset seizures in adult patients.
Abecma (idecabtagene vicleucel) Suspension for Intravenous Infusion
New Indication Approved: April 4, 2024
Date of Original Approval: March 26, 2021
Abecma (idecabtagene vicleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
Fanapt (iloperidone) Tablets
New Indication Approved: April 2, 2024
Date of Original Approval: May 6, 2009
Fanapt (iloperidone) is a 5HT2/D2 antagonist (atypical) antipsychotic for the treatment of schizophrenia, and the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
Vemlidy (tenofovir alafenamide) Tablets
Patient Population Altered: March 27, 2024
Date of Original Approval: November 10, 2016
Vemlidy (tenofovir alafenamide) is a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 6 years of age and older and weighing at least 25 kg with compensated liver disease.
Elahere (mirvetuximab soravtansine-gynx) Injection
Labeling Revision Approved: March 22, 2024
Date of Original Approval: November 14, 2022
Elahere (mirvetuximab soravtansine-gynx) is a folate receptor alpha (FRα)-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.
Nexletol (bempedoic acid) Tablets
New Indication Approved: March 22, 2024
Date of Original Approval: February 21, 2020
Nexletol (bempedoic acid) is an adenosine triphosphate-citrate lyase (ACL) inhibitor used for cardiovascular risk reduction and the treatment of primary hyperlipidemia.
Ultomiris (ravulizumab-cwvz) Injection
New Indication Approved: March 22, 2024
Date of Original Approval: December 21, 2018
Ultomiris (ravulizumab-cwvz) is a long-acting C5 complement inhibitor used for the treatment of paroxysmal nocturnal hemoglobinuria, hemolytic uremic syndrome, generalized myasthenia gravis, and neuromyelitis optica spectrum disorder.
Ixinity (coagulation factor IX (recombinant)) for Injection
Patient Population Altered: March 22, 2024
Date of Original Approval: April 29, 2015
Ixinity (coagulation factor IX (recombinant)) is a clotting factor IX therapy used to prevent bleeding in patients with hemophilia B.
Iclusig (ponatinib) Tablets
New Indication Approved: March 19, 2024
Date of Original Approval: December 14, 2012
Iclusig (ponatinib) is a kinase inhibitor used for the treatment of acute lymphoblastic leukemia and chronic myeloid leukemia.
Spevigo (spesolimab-sbzo) Injection
New Indication Approved: March 18, 2024
Date of Original Approval: September 1, 2022
Spevigo (spesolimab-sbzo) is an interleukin-36 receptor antagonist indicated for the treatment of generalized pustular psoriasis.
Xhance (fluticasone propionate) Nasal Spray
New Indication Approved: March 15, 2024
Date of Original Approval: September 18, 2017
Xhance (fluticasone propionate) is a topical nasal corticosteroid indicated for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) and chronic rhinosinusitis without nasal polyps (CRSsNP) in adults.
Edurant (rilpivirine) Tablets and Tablets for Oral Suspension
New Dosage Form Approved: March 15, 2024
Date of Original Approval: May 20, 2011
Edurant (rilpivirine) is a human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside reverse transcriptase inhibitor (NNRTI) used for the treatment of HIV-1 infection.
Breyanzi (lisocabtagene maraleucel) Suspension for Intravenous Infusion
New Indication Approved: March 14, 2024
Date of Original Approval: February 5, 2021
Breyanzi (lisocabtagene maraleucel) is a CD-19 directed chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL) and chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Livmarli (maralixibat) Oral Solution
New Indication Approved: March 13, 2024
Date of Original Approval: September 29, 2021
Livmarli (maralixibat) is an ileal bile acid transporter (IBAT) inhibitor used for the treatment of cholestatic pruritus in patients with Alagille syndrome or progressive familial intrahepatic cholestasis.
Wegovy (semaglutide) Injection
New Indication Approved: March 8, 2024
Date of Original Approval: June 4, 2021
Wegovy (semaglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist used for weight management and cardiovascular risk reduction in people with obesity or overweight.
Praluent (alirocumab) Injection
Patient Population Altered: March 8, 2024
Date of Original Approval: July 24, 2015
Praluent (alirocumab) is a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor monoclonal antibody used for the treatment of familial hypercholesterolemia and to reduce the risk of cardiovascular events in people with cardiovascular disease.
Brukinsa (zanubrutinib) Capsules
New Indication Approved: March 7, 2024
Date of Original Approval: November 14, 2019
Brukinsa (zanubrutinib) is a Bruton’s tyrosine kinase (BTK) inhibitor used for the treatment of mantle cell lymphoma, Waldenström’s macroglobulinemia, marginal zone lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma, and follicular lymphoma.
Opdivo (nivolumab) Injection
New Indication Approved: March 6, 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.
Besponsa (inotuzumab ozogamicin) for Injection
Patient Population Altered: March 6, 2024
Date of Original Approval: August 17, 2017
Besponsa (inotuzumab ozogamicin) is a CD22 monoclonal antibody and calicheamicin cytotoxic agent conjugate indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older.
Rybrevant (amivantamab-vmjw) Injection
New Indication Approved: March 1, 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 non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
Definity (perflutren lipid microsphere) Injectable Suspension
Patient Population Altered: March 1, 2024
Date of Original Approval: July 31, 2001
Definity (perflutren lipid microsphere) is an ultrasound contrast agent indicated, after activation, for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.
Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide) Tablets
New Indication Approved: February 23, 2024
Date of Original Approval: February 7, 2018
Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide) is a combination of an integrase strand transfer inhibitor (bictegravir) and two HIV-1 nucleoside analog reverse transcriptase inhibitors (emtricitabine and tenofovir alafenamide) used for the treatment of HIV-1 infection.
Imbruvica (ibrutinib) Capsules, Tablets and Oral Suspension
New Formulation Approved: February 22, 2024
Date of Original Approval: November 13, 2013
Imbruvica (ibrutinib) is an oral Bruton's tyrosine kinase (BTK) inhibitor for the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), Waldenström’s macroglobulinemia (WM), and chronic graft versus host disease (cGVHD).
Tecvayli (teclistamab-cqyv) Injection
New Dosage Regimen: February 20, 2024
Date of Original Approval: October 25, 2022
Tecvayli (teclistamab-cqyv) is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
Xolair (omalizumab) Injection
New Indication Approved: February 16, 2024
Date of Original Approval: June 20, 2003
Xolair (omalizumab) is an anti-IgE monoclonal antibody for use in the treatment of asthma, chronic rhinosinusitis with nasal polyps, IgE-mediated food allergy, and chronic spontaneous urticaria.
Tagrisso (osimertinib) Tablets
New Indication Approved: February 16, 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).
Tepmetko (tepotinib) Tablets
Labeling Revision Approved: February 15, 2024
Date of Original Approval: February 3, 2021
Tepmetko (tepotinib) is an oral MET inhibitor for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.
Onivyde (irinotecan liposomal) Injection
New Dosage Regimen: February 13, 2024
Date of Original Approval: October 22, 2015
Onivyde (irinotecan liposome injection) is a liposomal formulation of the topoisomerase I inhibitor irinotecan used in the treatment of pancreatic adenocarcinoma.
Yescarta (axicabtagene ciloleucel) Suspension for Intravenous Infusion
New Formulation Approved: January 30, 2024
Date of Original Approval: October 18, 2017
Yescarta (axicabtagene ciloleucel) is a CD19-directed genetically modified autologous T cell immunotherapy (CAR T-cell therapy) used for the treatment of large B-cell lymphoma and follicular lymphoma.
Gammagard Liquid (immune globulin infusion (human)) Solution
New Indication Approved: January 26, 2024
Date of Original Approval: April 27, 2005
Gammagard Liquid (immune globulin infusion (human) 10%) is an immune globulin infusion (human) indicated as replacement therapy in primary humoral immunodeficiency, multifocal motor neuropathy, and chronic inflammatory demyelinating polyneuropathy.
Dupixent (dupilumab) Injection
Patient Population Altered: January 25, 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, and prurigo nodularis.
Zynrelef (bupivacaine and meloxicam) Injection
New Indication Approved: January 23, 2024
Date of Original Approval: May 12, 2021
Zynrelef (bupivacaine and meloxicam) is an extended-release, fixed-dose combination of the local anesthetic bupivacaine and the nonsteroidal anti-inflammatory drug (NSAID) meloxicam indicated for the management of postoperative pain.
Balversa (erdafitinib) Tablets
Labeling Revision Approved: January 19, 2024
Date of Original Approval: April 12, 2019
Balversa (erdafitinib) is a pan-fibroblast growth factor receptor (FGFR) inhibitor for the treatment of patients with locally advanced or metastatic urothelial cancer (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy.
Casgevy (exagamglogene autotemcel) Suspension for Intravenous Infusion
New Indication Approved: January 16, 2024
Date of Original Approval: December 8, 2023
Casgevy (exagamglogene autotemcel) is a CRISPR/Cas9 genome-edited cell therapy for the treatment of sickle cell disease and transfusion-dependent beta-thalassemia.
Keytruda (pembrolizumab) for Injection
New Indication Approved: January 12, 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, and triple-negative breast cancer.
Hyqvia (immune globulin and hyaluronidase) Solution for Subcutaneous Administration
New Indication Approved: January 12, 2024
Date of Original Approval: September 12, 2014
Hyqvia (immune globulin and hyaluronidase) is an immune globulin with a recombinant human hyaluronidase combination used for the treatment of primary immunodeficiency (PI) and chronic inflammatory demyelinating polyneuropathy (CIDP).
Dupixent (dupilumab) Injection
Labeling Revision Approved: January 12, 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, and prurigo nodularis.
Udenyca (pegfilgrastim-cbqv) Injection
New Dosage Regimen: December 22, 2023
Date of Original Approval: November 2, 2018
Udenyca (pegfilgrastim-cbqv) is a PEGylated growth colony-stimulating factor biosimilar to Neulasta (pegfilgrastim) indicated to reduce the duration of febrile neutropenia in patients treated with chemotherapy and to increase survival in patients acutely exposed to myelosuppressive doses of radiation.
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