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.
Vaxneuvance (pneumococcal 15-valent conjugate vaccine) Injection
Patient Population Altered: June 17, 2022
Date of Original Approval: July 16, 2021
Vaxneuvance (pneumococcal 15-valent conjugate vaccine) is a vaccine indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in individuals 6 weeks of age and older.
Imcivree (setmelanotide) Injection
New Indication Approved: June 16, 2022
Date of Original Approval: November 25, 2020
Imcivree (setmelanotide) is a melanocortin 4 (MC4) receptor agonist for chronic weight management of obesity caused by proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency; or Bardet-Biedl syndrome.
Skyrizi (risankizumab-rzaa) Injection
New Indication Approved: June 16, 2022
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, and Crohn's disease.
Olumiant (baricitinib) Tablets
New Indication Approved: June 13, 2022
Date of Original Approval: May 31, 2018
Olumiant (baricitinib) is a Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis, COVID-19, and alopecia areata.
Dupixent (dupilumab) Injection
Patient Population Altered: June 7, 2022
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 (CRSwNP), and eosinophilic esophagitis.
CellCept (mycophenolate mofetil) Tablets, Capsules, Oral Suspension, Injection
Patient Population Altered: June 6, 2022
Date of Original Approval: May 3, 1995
CellCept (mycophenolate mofetil) is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants.
Riabni (rituximab-arrx) Injection
New Indication Approved: June 3, 2022
Date of Original Approval: December 17, 2020
Riabni (rituximab-arrx) is a CD20-directed cytolytic antibody biosimilar to Rituxan indicated for the treatment of adult patients with non-Hodgkin’s Lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis, and granulomatosis with polyangiitis (GPA) (Wegener’s Granulomatosis) and microscopic polyangiitis (MPA).
Opdivo (nivolumab) Injection
New Indication Approved: May 27, 2022
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.
Kymriah (tisagenlecleucel) Suspension for Intravenous Infusion
New Indication Approved: May 27, 2022
Date of Original Approval: August 30, 2017
Kymriah (tisagenlecleucel) is a chimeric antigen receptor T cell (CAR-T) therapy for the treatment of B-cell acute lymphoblastic leukemia (ALL), large B-cell lymphoma, and follicular lymphoma (FL).
Evrysdi (risdiplam) for Oral Solution
Patient Population Altered: May 27, 2022
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.
Beovu (brolucizumab-dbll) Injection
New Indication Approved: May 27, 2022
Date of Original Approval: October 7, 2019
Beovu (brolucizumab-dbll) is a human vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME).
Tibsovo (ivosidenib) Tablets
New Indication Approved: May 25, 2022
Date of Original Approval: July 20, 2018
Tibsovo (ivosidenib) is an isocitrate dehydrogenase-1 (IDH1) inhibitor used in the treatment of patients with IDH1-mutated acute myeloid leukemia (AML) and IDH1-mutated cholangiocarcinoma.
Tyvaso (treprostinil) Inhalation Solution
New Formulation Approved: May 23, 2022
Date of Original Approval: July 30, 2009
Tyvaso (treprostinil) is a prostacyclin mimetic used for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.
Dupixent (dupilumab) Injection
New Indication Approved: May 20, 2022
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 (CRSwNP), and eosinophilic esophagitis.
TPOXX (tecovirimat) Capsules and Injection
New Formulation Approved: May 18, 2022
Date of Original Approval: July 13, 2018
TPOXX (tecovirimat) is an orthopoxvirus-specific antiviral indicated for the treatment of human smallpox disease.
Olumiant (baricitinib) Tablets
New Indication Approved: May 10, 2022
Date of Original Approval: May 31, 2018
Olumiant (baricitinib) is a Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis, COVID-19, and alopecia areata.
Enhertu (fam-trastuzumab deruxtecan-nxki) Injection
New Indication Approved: May 4, 2022
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 and HER2-positive gastric or gastroesophageal junction adenocarcinoma.
Qelbree (viloxazine hydrochloride) Extended Release Capsules
Patient Population Altered: April 29, 2022
Date of Original Approval: April 2, 2021
Qelbree (viloxazine hydrochloride) is a serotonin norepinephrine modulating agent (SNMA) for the treatment of attention deficit hyperactivity disorder (ADHD) in in adults and pediatric patients 6 years and older.
Rinvoq (upadacitinib) Extended-Release Tablets
New Indication Approved: April 29, 2022
Date of Original Approval: August 16, 2019
Rinvoq (upadacitinib) is a Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, and ankylosing spondylitis.
Ultomiris (ravulizumab-cwvz) Injection
New Indication Approved: April 27, 2022
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, and generalized myasthenia gravis.
Caplyta (lumateperone) Capsules
New Formulation Approved: April 26, 2022
Date of Original Approval: December 20, 2019
Caplyta (lumateperone) is an atypical antipsychotic for the treatment of schizophrenia and bipolar depression.
Veklury (remdesivir) Injection
Patient Population Altered: April 25, 2022
Date of Original Approval: October 22, 2020
Veklury (remdesivir) is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor indicated for the treatment of COVID-19.
Yescarta (axicabtagene ciloleucel) Suspension for Intravenous Infusion
New Indication Approved: April 1, 2022
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.
Triumeq (abacavir, dolutegravir and lamivudine) Tablets
New Dosage Form Approved: March 30, 2022
Date of Original Approval: August 22, 2014
Triumeq (abacavir, dolutegravir and lamivudine) is a fixed-dose combination containing the INSTI dolutegravir and the NRTIs abacavir and lamivudine for the treatment of HIV-1 infection.
Cabenuva (cabotegravir and rilpivirine) Extended-Release Injectable Suspension ( Co-Packaged)
Patient Population Altered: March 29, 2022
Date of Original Approval: January 21, 2021
Cabenuva (cabotegravir and rilpivirine) is a long-acting, injectable regimen of the HIV-1 integrase strand transfer inhibitor (INSTI) cabotegravir, and the HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older.
Ozempic (semaglutide) Injection
New Dosage Regimen: March 28, 2022
Date of Original Approval: December 5, 2017
Ozempic (semaglutide) is a glucagon-like peptide-1 (GLP-1) analog indicated:
- as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
- to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.
Fintepla (fenfluramine) Oral Solution
New Indication Approved: March 25, 2022
Date of Original Approval: June 25, 2020
Fintepla (fenfluramine) is an amphetamine derivative indicated for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older.
Cabenuva (cabotegravir and rilpivirine) Extended-Release Injectable Suspension ( Co-Packaged)
Labeling Revision Approved: March 23, 2022
Date of Original Approval: January 21, 2021
Cabenuva (cabotegravir and rilpivirine) is a long-acting, injectable regimen of the HIV-1 integrase strand transfer inhibitor (INSTI) cabotegravir, and the HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older.
Keytruda (pembrolizumab) for Injection
New Indication Approved: March 21, 2022
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, Merkel cell carcinoma, renal cell carcinoma, endometrial carcinoma, tumor mutational burden-high (TMB-H) cancer, cutaneous squamous cell carcinoma, and triple-negative breast cancer.
Rinvoq (upadacitinib) Extended-Release Tablets
New Indication Approved: March 16, 2022
Date of Original Approval: August 16, 2019
Rinvoq (upadacitinib) is a Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, and ankylosing spondylitis.
Lynparza (olaparib) Tablets
New Indication Approved: March 11, 2022
Date of Original Approval: December 19, 2014
Lynparza (olaparib) is a first-in-class oral poly ADP ribose polymerase (PARP) inhibitor indicated for the treatment of ovarian cancer, breast cancer, pancreatic cancer, and prostate cancer.
Opdivo (nivolumab) Injection
New Indication Approved: March 4, 2022
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.
Jardiance (empagliflozin) Tablets
New Indication Approved: February 24, 2022
Date of Original Approval: August 1, 2014
Jardiance (empagliflozin) is a sodium glucose co-transporter-2 (SGLT2) inhibitor for the treatment of type 2 diabetes, to reduce the risk of cardiovascular death in patients with type 2 diabetes mellitus and established cardiovascular disease, and to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure and reduced ejection fraction.
Takhzyro (lanadelumab-flyo) Injection
New Formulation Approved: February 9, 2022
Date of Original Approval: August 23, 2018
Takhzyro (lanadelumab-flyo) is a plasma kallikrein inhibitor (monoclonal antibody) for the prevention of angioedema attacks in patients with hereditary angioedema.
Juvederm (dermal filler)
New Indication Approved: February 8, 2022
Date of Original Approval: June 2, 2006
Juvederm is a hyaluronic acid dermal filler indicated for the correction of facial wrinkles and folds.
Vonvendi (von willebrand factor (recombinant)) for Injection
New Indication Approved: January 31, 2022
Date of Original Approval: December 8, 2015
Vonvendi (von Willebrand factor (recombinant)) is a recombinant von Willebrand factor for the treatment of von Willebrand disease(VWD).
Yescarta (axicabtagene ciloleucel) Suspension for Intravenous Infusion
Labeling Revision Approved: January 31, 2022
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.
Cabenuva (cabotegravir and rilpivirine) Extended-Release Injectable Suspension ( Co-Packaged)
New Dosage Regimen: January 31, 2022
Date of Original Approval: January 21, 2021
Cabenuva (cabotegravir and rilpivirine) is a long-acting, injectable regimen of the HIV-1 integrase strand transfer inhibitor (INSTI) cabotegravir, and the HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older.
Solosec (secnidazole) Oral Granules
Patient Population Altered: January 26, 2022
Date of Original Approval: September 15, 2017
Solosec (secnidazole) is a nitroimidazole antimicrobial for use as a single-dose oral therapy in the treatment of bacterial vaginosis (BV) and trichomoniasis.
Nucala (mepolizumab) Injection
New Dosage Regimen: January 24, 2022
Date of Original Approval: November 4, 2015
Nucala (mepolizumab) is an interleukin-5 antagonist monoclonal antibody (IgG1 kappa) used for the treatment of with severe eosinophilic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome), and hypereosinophilic syndrome (HES).
Veklury (remdesivir) Injection
New Indication Approved: January 21, 2022
Date of Original Approval: October 22, 2020
Veklury (remdesivir) is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor indicated for the treatment of COVID-19.
Skyrizi (risankizumab-rzaa) Injection
New Indication Approved: January 21, 2022
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, and Crohn's disease.
Rinvoq (upadacitinib) Extended-Release Tablets
New Indication Approved: January 14, 2022
Date of Original Approval: August 16, 2019
Rinvoq (upadacitinib) is a Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, and ankylosing spondylitis.
Cosentyx (secukinumab) Injection
Patient Population Altered: December 22, 2021
Date of Original Approval: January 21, 2015
Cosentyx (secukinumab) is a selective interleukin-17A (IL-17A) inhibitor for the treatment of plaque psoriasis, ankylosing spondylitis, psoriatic arthritis, and non-radiographic axial spondyloarthritis.
Xarelto (rivaroxaban) Tablets and Oral Suspension
Patient Population Altered: December 20, 2021
Date of Original Approval: July 1, 2011
Xarelto (rivaroxaban) is a factor Xa inhibitor used for the treatment and prevention of blood clots that are related to certain conditions involving the heart and blood vessels.
Otezla (apremilast) Tablets
New Indication Approved: December 20, 2021
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.
Oxbryta (voxelotor) Tablets
Patient Population Altered: December 17, 2021
Date of Original Approval: November 25, 2019
Oxbryta (voxelotor) is an oral, HbS (sickle hemoglobin) polymerization inhibitor for the treatment of patients with sickle cell disease (SCD).
Caplyta (lumateperone) Capsules
New Indication Approved: December 17, 2021
Date of Original Approval: December 20, 2019
Caplyta (lumateperone) is an atypical antipsychotic for the treatment of schizophrenia and bipolar depression.
Orencia (abatacept) Injection
New Indication Approved: December 15, 2021
Date of Original Approval: December 23, 2005
Orencia (abatacept) is a selective T cell costimulation modulator indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and the prophylaxis of acute graft versus host disease (aGVHD).
Xeljanz (tofacitinib) Tablets and Oral Solution
New Indication Approved: December 14, 2021
Date of Original Approval: November 6, 2012
Xeljanz (tofacitinib) is an oral Janus kinase (JAK) inhibitor used for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis.
See also: New Drug Approvals, New Drug Applications, Recent Additions to Drugs.com
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