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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.

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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