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.
Epkinly (epcoritamab-bysp) Injection
New Indication Approved: June 26, 2024
Date of Original Approval: May 19, 2023
Epkinly (epcoritamab-bysp) is a bispecific CD20-directed CD3 T-cell engager for use in the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
Krazati (adagrasib) Tablets
New Indication Approved: June 21, 2024
Date of Original Approval: December 12, 2022
Krazati (adagrasib) is a small-molecule inhibitor of KRAS G12C for the treatment of adult patients with KRAS G12C-mutated non-small cell lung cancer and KRAS G12C-mutated colorectal cancer.
Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) Injection
New Indication Approved: June 21, 2024
Date of Original Approval: June 20, 2023
Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) is a neonatal Fc receptor blocker and endoglycosidase combination used for the treatment of generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy.
Wakix (pitolisant) Tablets
Patient Population Altered: June 21, 2024
Date of Original Approval: August 14, 2019
Wakix (pitolisant) is a histamine-3 (H₃) receptor antagonist/inverse agonist for the treatment of narcolepsy.
Sirturo (bedaquiline) Tablets
Labeling Revision Approved: June 21, 2024
Date of Original Approval: December 28, 2012
Sirturo (bedaquiline) is an oral diarylquinoline antimycobacterial drug for the treatment of pulmonary multi-drug resistant tuberculosis.
Elevidys (delandistrogene moxeparvovec-rokl) Suspension for Intravenous Infusion
Patient Population Altered: June 20, 2024
Date of Original Approval: June 22, 2023
Elevidys (delandistrogene moxeparvovec-rokl) is an adeno-associated virus vector-based gene therapy for the treatment of patients at least 4 years of age with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene.
Skyrizi (risankizumab-rzaa) Injection
New Indication Approved: June 18, 2024
Date of Original Approval: April 23, 2019
Skyrizi (risankizumab-rzaa) is an interleukin-23 (IL-23) inhibitor for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
Keytruda (pembrolizumab) for Injection
New Indication Approved: June 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, and triple-negative breast cancer.
Blincyto (blinatumomab) Injection
New Indication Approved: June 14, 2024
Date of Original Approval: December 3, 2014
Blincyto (blinatumomab) is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of certain types of B-cell acute lymphoblastic leukemia (ALL).
Imfinzi (durvalumab) Injection
New Indication Approved: June 14, 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.
Augtyro (repotrectinib) Capsules
New Indication Approved: June 14, 2024
Date of Original Approval: November 15, 2023
Augtyro (repotrectinib) is a tyrosine kinase inhibitor (TKI) for the treatment of patients with ROS1-positive non-small cell lung cancer (NSCLC) and NTRK-positive metastatic solid tumors.
Farxiga (dapagliflozin) Tablets
Patient Population Altered: June 12, 2024
Date of Original Approval: January 8, 2014
Farxiga (dapagliflozin) is a sodium-glucose cotransporter 2 (SGLT2) inhibitor for use in the treatment of type 2 diabetes mellitus, heart failure, and chronic kidney disease.
Xigduo XR (dapagliflozin and metformin hydrochloride) Extended-Release Tablets
Patient Population Altered: June 12, 2024
Date of Original Approval: October 30, 2014
Xigduo XR (dapagliflozin and metformin hydrochloride) is a once-daily sodium-glucose cotransporter 2 (SGLT2) inhibitor and biguanide combination for the treatment of type 2 diabetes.
Adbry (tralokinumab-ldrm) Injection
New Formulation Approved: June 12, 2024
Date of Original Approval: December 27, 2021
Adbry (tralokinumab-ldrm) is an interleukin-13 antagonist used for the treatment of moderate-to-severe atopic dermatitis.
Retevmo (selpercatinib) Capsules and Tablets
Labeling Revision Approved: June 12, 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.
Kevzara (sarilumab) Injection
New Indication Approved: June 10, 2024
Date of Original Approval: May 22, 2017
Kevzara (sarilumab) is an interleukin-6 (IL-6) receptor antagonist for the treatment of rheumatoid arthritis, polymyalgia rheumatica and polyarticular juvenile idiopathic arthritis.
Arexvy (respiratory syncytial virus vaccine, adjuvanted) Suspension for Intramuscular Injection
Patient Population Altered: June 7, 2024
Date of Original Approval: May 3, 2023
Arexvy (respiratory syncytial virus vaccine, adjuvanted) is a vaccine used for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus.
Klisyri (tirbanibulin) Ointment
New Dosage Regimen: June 7, 2024
Date of Original Approval: December 14, 2020
Klisyri (tirbanibulin) is a first-in-class dual Src Kinase and tubulin polymerization inhibitor for the topical treatment of actinic keratosis on the face or scalp.
Breyanzi (lisocabtagene maraleucel) Suspension for Intravenous Infusion
New Indication Approved: May 30, 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, chronic lymphocytic leukemia or small lymphocytic lymphoma, follicular lymphoma, and mantle cell lymphoma.
Firdapse (amifampridine phosphate) Tablets
New Dosage Regimen: May 30, 2024
Date of Original Approval: November 28, 2018
Firdapse (amifampridine phosphate) is a nonspecific, voltage-dependent, potassium (K+) channel blocker for the treatment of Lambert Eaton myasthenic syndrome (LEMS) in adults and pediatric patients six years of age and older.
Retevmo (selpercatinib) Capsules and Tablets
New Indication Approved: May 29, 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.
Austedo XR (deutetrabenazine) Extended-Release Tablets
New Formulation Approved: May 29, 2024
Date of Original Approval: February 17, 2023
Austedo XR (deutetrabenazine) is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated in adults for the treatment of tardive dyskinesia, and chorea associated with Huntington’s disease.
Benlysta (belimumab) Injection
New Dosage Regimen: May 16, 2024
Date of Original Approval: March 10, 2011
Benlysta (belimumab) is B-lymphocyte stimulator (BLyS)-specific inhibitor for the treatment of active systemic lupus erythematosus (SLE) and active lupus nephritis.
Breyanzi (lisocabtagene maraleucel) Suspension for Intravenous Infusion
New Indication Approved: May 15, 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, chronic lymphocytic leukemia or small lymphocytic lymphoma, follicular lymphoma, and mantle cell lymphoma.
Altuviiio (antihemophilic factor recombinant, Fc-VWF-XTEN fusion protein-ehtl) Lyophilized Powder for Injection
Labeling Revision Approved: May 10, 2024
Date of Original Approval: February 22, 2023
Altuviiio [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl] is a recombinant DNA-derived, factor VIII concentrate indicated for use in people with hemophilia A.
Ingrezza (valbenazine) Capsules and Sprinkle 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.
Otezla (apremilast) Tablets
Patient Population Altered: April 25, 2024
Date of Original Approval: March 21, 2014
Otezla (apremilast) is a phosphodiesterase 4 (PDE4) inhibitor indicated for the treatment of psoriatic arthritis, plaque psoriasis, and oral ulcers associated with Behçet’s Disease.
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.
Clinolipid (lipid injectable emulsion) for Intravenous Use
Patient Population Altered: April 24, 2024
Date of Original Approval: October 3, 2013
Clinolipid (lipid injectable emulsion) is an intravenous fat supplement used for parenteral nutrition.
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.
Hyrimoz (adalimumab-adaz) Injection
Labeling Revision Approved: April 5, 2024
Date of Original Approval: October 30, 2018
Hyrimoz (adalimumab-adaz) is an anti-TNF-α monoclonal antibody 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.
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.
See also: New Drug Approvals, New Drug Applications, Recent Additions to Drugs.com