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.
Tremfya (guselkumab) Injection
New Indication Approved: September 11, 2024
Date of Original Approval: July 13, 2017
Tremfya (guselkumab) is an interleukin-23 blocker for the treatment of plaque psoriasis, psoriatic arthritis and ulcerative colitis.
Filspari (sparsentan) Tablets
New Indication Approved: September 5, 2024
Date of Original Approval: February 17, 2023
Filspari (sparsentan) is an endothelin and angiotensin II receptor antagonist indicated to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.
ACAM2000 (Smallpox and Mpox (Vaccinia) Vaccine, Live)
New Indication Approved: August 29, 2024
Date of Original Approval: August 31, 2007
ACAM2000 [Smallpox and Mpox (Vaccinia) Vaccine, Live] is a live vaccinia virus vaccine indicated for active immunization for the prevention of smallpox and mpox disease in individuals determined to be at high risk for smallpox or mpox infection.
Spikevax (Moderna COVID-19 Vaccine) (COVID-19 Vaccine, mRNA) Injection
New Formulation Approved: August 22, 2024
Date of Original Approval: January 31, 2022
Spikevax (COVID-19 Vaccine, mRNA) and Moderna COVID-19 Vaccine are mRNA vaccines for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Comirnaty (COVID-19 Vaccine, mRNA) Injection
New Formulation Approved: August 22, 2024
Date of Original Approval: August 23, 2021
Comirnaty (COVID-19 Vaccine, mRNA) and Pfizer-BioNTech COVID-19 Vaccine are mRNA vaccines indicated for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Imfinzi (durvalumab) Injection
New Indication Approved: August 15, 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.
NexoBrid (anacaulase-bcdb) Lyophilized Powder for Topical Gel
Patient Population Altered: August 15, 2024
Date of Original Approval: December 28, 2022
NexoBrid (anacaulase-bcdb) is a concentrate of proteolytic enzymes indicated for eschar removal in adult and pediatric patients with deep partial thickness and/or full thickness thermal burns.
Furoscix (furosemide) Injection
New Indication Approved: August 9, 2024
Date of Original Approval: October 7, 2022
Furoscix (furosemide) is a loop diuretic indicated for the at-home treatment of congestion due to fluid overload in adults with chronic heart failure.
Fabhalta (iptacopan) Capsules
New Indication Approved: August 7, 2024
Date of Original Approval: December 5, 2023
Fabhalta (iptacopan) is a complement factor B inhibitor used for the treatment of paroxysmal nocturnal hemoglobinuria and primary immunoglobulin A nephropathy.
Jemperli (dostarlimab-gxly) Injection
Labeling Revision Approved: August 1, 2024
Date of Original Approval: April 22, 2021
Jemperli (dostarlimab-gxly) is a programmed death receptor-1 (PD-1)–blocking antibody for the treatment of endometrial cancer, and mismatch repair deficient (dMMR) solid tumors.
Darzalex Faspro (daratumumab and hyaluronidase-fihj) Injection
New Dosage Regimen: July 30, 2024
Date of Original Approval: May 1, 2020
Darzalex Faspro (daratumumab and hyaluronidase-fihj) is a combination of daratumumab, a CD38-directed cytolytic antibody, and hyaluronidase, an endoglycosidase, indicated for the treatment of multiple myeloma and light chain (AL) amyloidosis.
Palforzia (Peanut (Arachis hypogaea) Allergen Powder-dnfp) Capsules and Sachets
Patient Population Altered: July 26, 2024
Date of Original Approval: January 31, 2020
Palforzia (Peanut (Arachis hypogaea) Allergen Powder-dnfp) is an oral immunotherapy indicated to help reduce the severity of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut.
Brineura (cerliponase alfa) Injection
Patient Population Altered: July 24, 2024
Date of Original Approval: April 27, 2017
Brineura (cerliponase alfa) is an enzyme replacement therapy for the restoration of tripeptidyl peptidase-1 (TPP1) enzyme activity in patients with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), or TPP1 deficiency, a form of Batten disease.
Livmarli (maralixibat) Oral Solution
Patient Population Altered: July 24, 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.
Zituvimet (metformin hydrochloride and sitagliptin) Tablets
New Formulation Approved: July 18, 2024
Date of Original Approval: November 3, 2023
Zituvimet (metformin hydrochloride and sitagliptin) is a biguanide and dipeptidyl peptidase-4 (DPP-4) inhibitor combination indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Xembify (immune globulin subcutaneous, human - klhw) Injection
Labeling Revision Approved: July 18, 2024
Date of Original Approval: July 3, 2019
Xembify (immune globulin subcutaneous, human- klhw) is a 20% immune globulin solution for subcutaneous injection indicated for treatment of Primary Humoral Immunodeficiency (PI) in patients 2 years of age and older.
Voquezna (vonoprazan) Tablets
New Indication Approved: July 17, 2024
Date of Original Approval: November 1, 2023
Voquezna (vonoprazan) is a potassium-competitive acid blocker (P-CAB) for use in the treatment of erosive and non-erosive gastroesophageal reflux disease (GERD) and the combination treatment of Helicobacter pylori infection.
Zoryve (roflumilast) Cream and Foam
New Indication Approved: July 9, 2024
Date of Original Approval: July 29, 2022
Zoryve (roflumilast) is a topical phosphodiesterase 4 (PDE4) inhibitor indicated for the treatment of plaque psoriasis (0.3% cream formulation), atopic dermatitis (0.15% cream formulation) and seborrheic dermatitis (0.3% foam formulation).
Xeomin (incobotulinumtoxinA) Injection
New Indication Approved: July 5, 2024
Date of Original Approval: July 30, 2010
Xeomin (incobotulinumtoxinA) is a botulinum toxin type A neurotoxin used for the treatment of chronic sialorrhea, upper limb spasticity, cervical dystonia, blepharospasm, and upper facial lines.
Vabysmo (faricimab-svoa) Intravitreal Injection
New Dosage Form Approved: July 3, 2024
Date of Original Approval: January 28, 2022
Vabysmo (faricimab-svoa) is a vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) inhibitor indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO).
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 diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma.
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.
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