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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.

Venclexta (venetoclax) Tablets

New Indication Approved: November 21, 2018
Date of Original Approval: April 11, 2016

Venclexta (venetoclax) is an oral B-cell lymphoma-2 (BCL-2) inhibitor for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with or without 17p deletion who have received at least 1 prior treatment; and for the combination treatment of newly-diagnosed acute myeloid leukemia (AML) in patients who are 75 years of age of over, or have other medical conditions that prevent the use of standard chemotherapy.

Actemra (tocilizumab) Injection

New Dosage Form Approved: November 19, 2018
Date of Original Approval: January 8, 2010

Actemra (tocilizumab) is a humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody for the treatment rheumatoid arthritis; systemic juvenile idiopathic arthritis (SJIA); polyarticular juvenile idiopathic arthritis (PJIA); giant cell arteritis; and CAR T cell-induced severe or life-threatening cytokine release syndrome.

Adcetris (brentuximab vedotin) Injection

New Indication Approved: November 16, 2018
Date of Original Approval: August 19, 2011

Adcetris (brentuximab vedotin) is a CD30-directed antibody-drug conjugate (ADC) indicated for the treatment of Hodgkin lymphoma, anaplastic large cell lymphoma, and CD30-expressing mycosis fungoides.

Promacta (eltrombopag) Tablets

New Indication Approved: November 16, 2018
Date of Original Approval: November 20, 2008

Promacta (eltrombopag) is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura, thrombocytopenia in patients with chronic hepatitis C, and patients with severe aplastic anemia.

Keytruda (pembrolizumab) for Injection

New Indication Approved: November 9, 2018
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 cancer, gastric cancer, cervical cancer, and hepatocellular carcinoma.

Empliciti (elotuzumab) Injection

New Dosage Regimen: November 6, 2018
Date of Original Approval: November 30, 2015

Empliciti (elotuzumab) is a Signaling Lymphocyte Activation Molecule (SLAMF7)-directed immunostimulatory antibody indicated for the combination treatment of patients with multiple myeloma.

Keytruda (pembrolizumab) for Injection

New Indication Approved: October 30, 2018
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 cancer, gastric cancer, cervical cancer, and hepatocellular carcinoma.

Invokana (canagliflozin) Tablets

New Indication Approved: October 30, 2018
Date of Original Approval: March 29, 2013

Invokana (canagliflozin) is a selective sodium glucose co-transporter 2 (SGLT2) inhibitor indicated for the treatment of type 2 diabetes, and to reduce the risk of cardiovascular events (including heart attack, stroke or death) in adults with type 2 diabetes and established cardiovascular disease.

Dupixent (dupilumab) Injection

New Indication Approved: October 19, 2018
Date of Original Approval: March 28, 2017

Dupixent (dupilumab) is an interleukin-4 receptor alpha antagonist indicated for the treatment of adult patients with inadequately controlled moderate-to-severe atopic dermatitis, and as an add-on maintenance treatment in patients aged 12 years and older with moderate-to-severe asthma.

Liletta (levonorgestrel) Intrauterine Device

New Dosage Regimen: October 15, 2018
Date of Original Approval: February 26, 2015

Liletta (levonorgestrel) is a hormonal intrauterine device (IUD) for use by women to prevent pregnancy for up to five years.

Xarelto (rivaroxaban) Tablets

New Indication Approved: October 11, 2018
Date of Original Approval: July 1, 2011

Xarelto (rivaroxaban) is a factor Xa inhibitor indicated:

  • to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation
  • for the treatment of deep vein thrombosis (DVT)
  • for the treatment of pulmonary embolism (PE)
  • for the reduction in the risk of recurrence of DVT and/or PE in patients at continued risk for recurrent DVT and/or PE after completion of initial treatment lasting at least 6 months
  • for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery
  • in combination with aspirin, to reduce the risk of major cardiovascular events (cardiovascular (CV) death, myocardial infarction (MI) and stroke) in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD)

Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant) Injection

Patient Population Altered: October 5, 2018
Date of Original Approval: December 10, 2014

Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant) is a 9-valent HPV vaccine for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58.

Hemlibra (emicizumab-kxwh) Injection

New Indication Approved: October 4, 2018
Date of Original Approval: November 16, 2017

Hemlibra (emicizumab-kxwh) is a bispecific factor IXa- and factor X-directed antibody indicated to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors.

Ixiaro (Japanese Encephalitis Virus Vaccine, Inactivated, Adsorbed)

New Dosage Regimen: October 4, 2018
Date of Original Approval: March 30, 2009

Ixiaro (Japanese Encephalitis Virus Vaccine, Inactivated, Adsorbed) is a purified, inactivated product for active immunization against viral infections of Japanese Encephalitis.

Xolair (omalizumab) Subcutaneous Injection

New Formulation Approved: September 28, 2018
Date of Original Approval: June 20, 2003

Xolair (omalizumab) is a monoclonal antibody indicated for the treatment of patients with moderate to severe persistent asthma, and chronic idiopathic urticaria.

Fycompa (perampanel) Tablets and Oral Suspension

Patient Population Altered: September 28, 2018
Date of Original Approval: October 22, 2012

Fycompa (perampanel) is a non-competitive AMPA glutamate receptor antagonist indicated for the treatment of partial-onset seizures, and as adjunctive therapy in the treatment of primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy.

Kyprolis (carfilzomib) Injection

New Dosage Regimen: September 28, 2018
Date of Original Approval: July 20, 2012

Kyprolis (carfilzomib) is a proteasome inhibitor indicated for the treatment of patients with multiple myeloma.

Symjepi (epinephrine) Injection

Patient Population Altered: September 27, 2018
Date of Original Approval: June 15, 2017

Symjepi (epinephrine) is a non-selective alpha and betaadrenergic receptor agonist in a single-dose, pre-filled syringe for use the emergency treatment of allergic reactions (Type I) including anaphylaxis.

Actemra (tocilizumab) Injection

New Dosage Regimen: September 12, 2018
Date of Original Approval: January 8, 2010

Actemra (tocilizumab) is a humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody for the treatment rheumatoid arthritis; systemic juvenile idiopathic arthritis (SJIA); polyarticular juvenile idiopathic arthritis (PJIA); giant cell arteritis; and CAR T cell-induced severe or life-threatening cytokine release syndrome.

Imbruvica (ibrutinib) Capsules and Tablets

New Indication Approved: August 24, 2018
Date of Original Approval: November 13, 2013

Imbruvica (ibrutinib) is an oral Bruton's tyrosine kinase (BTK) inhibitor for the treatment of mantle cell lymphoma, chronic lymphocytic leukemia, Waldenström’s macroglobulinemia, small lymphocytic lymphoma, marginal zone lymphoma, and chronic graft versus host disease.

Keytruda (pembrolizumab) for Injection

Labeling Revision Approved: August 20, 2018
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 cancer, gastric cancer, cervical cancer, and hepatocellular carcinoma.

Opdivo (nivolumab) Injection

New Indication Approved: August 16, 2018
Date of Original Approval: December 22, 2014

Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of advanced melanoma, advanced non-small cell lung cancer, advanced small cell lung cancer, advanced renal cell carcinoma, classical Hodgkin lymphoma, advanced squamous cell carcinoma of the head and neck, urothelial carcinoma, MSI-H or dMMR metastatic colorectal cancer, and hepatocellular carcinoma.

Eylea (aflibercept) Injection

New Dosage Regimen: August 16, 2018
Date of Original Approval: November 18, 2011

Eylea (aflibercept) is a VEGF inhibitor indicated for the treatment of patients with neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.

Lenvima (lenvatinib) Capsules

New Indication Approved: August 15, 2018
Date of Original Approval: February 13, 2015

Lenvima (lenvatinib) is a multiple receptor tyrosine kinase (RTK) inhibitor for the treatment of progressive radioiodine-refractory differentiated thyroid cancer, advanced renal cell carcinoma, and hepatocellular carcinoma.

Kalydeco (ivacaftor) Tablets and Oral Granules

Patient Population Altered: August 15, 2018
Date of Original Approval: January 31, 2012

Kalydeco (ivacaftor) is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator indicated for the treatment of cystic fibrosis (CF) in patients ages one year and older who have one mutation in the CFTR gene that is responsive to ivacaftor.

Orkambi (ivacaftor and lumacaftor) Tablets and Oral Granules

New Dosage Form Approved: August 7, 2018
Date of Original Approval: July 2, 2015

Orkambi (ivacaftor and lumacaftor) is a CFTR potentiator and CFTR corrector combination for the treatment of the underlying cause of cystic fibrosis in patients 2 years and older with two copies of the F508del mutation in their CFTR gene.

Granix (tbo-filgrastim) Injection

New Indication Approved: July 31, 2018
Date of Original Approval: August 29, 2012

Granix (tbo-filgrastim) is a leukocyte growth factor indicated for the reduction in the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs.

Remodulin (treprostinil) Injection

New Formulation Approved: July 30, 2018
Date of Original Approval: May 21, 2002

Remodulin (treprostinil) is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension.

Kisqali (ribociclib) Tablets

New Indication Approved: July 18, 2018
Date of Original Approval: March 13, 2017

Kisqali (ribociclib) is an inhibitor of cyclin-dependent kinase (CDK) 4 and 6 indicated for the combination treatment of pre/perimenopausal or postmenopausal women with HR+/HER2- metastatic breast cancer.

Xtandi (enzalutamide) Capsules

New Indication Approved: July 13, 2018
Date of Original Approval: August 31, 2012

Xtandi (enzalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with castration-resistant prostate cancer.

Opdivo (nivolumab) Injection

New Indication Approved: July 11, 2018
Date of Original Approval: December 22, 2014

Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of advanced melanoma, advanced non-small cell lung cancer, advanced small cell lung cancer, advanced renal cell carcinoma, classical Hodgkin lymphoma, advanced squamous cell carcinoma of the head and neck, urothelial carcinoma, MSI-H or dMMR metastatic colorectal cancer, and hepatocellular carcinoma.

Xeomin (incobotulinumtoxinA) Injection

New Indication Approved: July 3, 2018
Date of Original Approval: July 30, 2010

Xeomin (incobotulinumtoxinA) is a botulinum toxin type A for the treatment of cervical dystonia, blepharospasm, glabellar lines, upper limb spasticity, and excessive drooling.

Nuplazid (pimavanserin) Tablets and Capsules

New Dosage Form Approved: June 29, 2018
Date of Original Approval: April 29, 2016

Nuplazid (pimavanserin) is a non-dopaminergic, selective serotonin inverse agonist (SSIA) for the treatment of psychosis associated with Parkinson’s disease.

Aristada (aripiprazole lauroxil) Injection

New Dosage Form Approved: June 29, 2018
Date of Original Approval: October 5, 2015

Aristada (aripiprazole lauroxil) is an extended-release injectable atypical antipsychotic with one-month, six-week, and two-month dosing options for the treatment of schizophrenia.

Cinryze (C1 esterase inhibitor (human)) Injection

Patient Population Altered: June 20, 2018
Date of Original Approval: October 10, 2008

Cinryze is a C1-esterase inhibitor indicated for routine prophylaxis against angioedema attacks in patients with hereditary angioedema (HAE).

Avastin (bevacizumab) Injection

New Indication Approved: June 13, 2018
Date of Original Approval: February 26, 2004

Avastin (bevacizumab) is a recombinant humanized monoclonal IgG1 antibody for the treatment of colorectal cancer, non-small cell lung cancer, glioblastoma, renal cell carcinoma, cervical cancer, ovarian cancer, fallopian tube cancer, and peritoneal cancer.

Keytruda (pembrolizumab) for Injection

New Indication Approved: June 13, 2018
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 cancer, gastric cancer, cervical cancer, and hepatocellular carcinoma.

Keytruda (pembrolizumab) for Injection

New Indication Approved: June 12, 2018
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 cancer, gastric cancer, cervical cancer, and hepatocellular carcinoma.

Venclexta (venetoclax) Tablets

New Indication Approved: June 8, 2018
Date of Original Approval: April 11, 2016

Venclexta (venetoclax) is an oral B-cell lymphoma-2 (BCL-2) inhibitor for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with or without 17p deletion who have received at least 1 prior treatment; and for the combination treatment of newly-diagnosed acute myeloid leukemia (AML) in patients who are 75 years of age of over, or have other medical conditions that prevent the use of standard chemotherapy.

Rituxan (rituximab) Injection for Intravenous Use

New Indication Approved: June 7, 2018
Date of Original Approval: November 26, 1997

Rituxan (rituximab) is a CD20-directed cytolytic antibody indicated for the treatment of patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, Wegener's granulomatosus, microscopic polyangiitis, and pemphigus vulgaris.

Mircera (epoetin beta-methoxy polyethylene glycol) Injection

Patient Population Altered: June 7, 2018
Date of Original Approval: November 14, 2007

Mircera (epoetin beta-methoxy polyethylene glycol) is an erythropoiesis-stimulating agent indicated for the treatment of anemia associated with chronic renal failure.

Xeljanz (tofacitinib) Tablets

New Indication Approved: May 30, 2018
Date of Original Approval: November 6, 2012

Xeljanz (tofacitinib) is an oral Janus kinase (JAK) inhibitor for the treatment of adult patients with moderately to severely active rheumatoid arthritis, active psoriatic arthritis, and moderately to severely active ulcerative colitis.

Cimzia (certolizumab pegol) Injection

New Indication Approved: May 25, 2018
Date of Original Approval: April 22, 2008

Cimzia (certolizumab) is a PEGylated anti-TNF (tumor necrosis factor) biologic therapy for the treatment of Crohn’s disease, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.

Prolia (denosumab) Injection

New Indication Approved: May 18, 2018
Date of Original Approval: June 1, 2010

Prolia is a RANK ligand (RANKL) inhibitor indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, for the treatment of bone loss in patients with prostate or breast cancer undergoing hormone ablation therapy, as a treatment to increase bone mass in men with osteoporosis at high risk for fracture, and for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture.

Arnuity Ellipta (fluticasone furoate) Inhalation Powder

Patient Population Altered: May 17, 2018
Date of Original Approval: August 20, 2014

Arnuity Ellipta (fluticasone furoate inhalation powder) is a once-daily inhaled corticosteroid for the maintenance treatment of asthma.

Taltz (ixekizumab) Injection

New Indication Approved: May 17, 2018
Date of Original Approval: March 22, 2016

Taltz (ixekizumab) is a humanized interleukin-17A antagonist indicated for the treatment of plaque psoriasis and psoriatic arthritis.

Truvada (emtricitabine and tenofovir) Tablets

Patient Population Altered: May 15, 2018
Date of Original Approval: August 2, 2004

Truvada (emtricitabine and tenofovir disoproxil fumarate) is a combination of nucleoside analog HIV-1 reverse transcriptase inhibitors indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection, and for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in people at high risk.

Gilenya (fingolimod) Capsules

Patient Population Altered: May 11, 2018
Date of Original Approval: September 21, 2010

Gilenya (fingolimod) is a sphingosine 1-phosphate receptor modulator indicated for the treatment of patients with relapsing forms of multiple sclerosis.

Actemra (tocilizumab) Injection

New Dosage Regimen: May 11, 2018
Date of Original Approval: January 8, 2010

Actemra (tocilizumab) is a humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody for the treatment rheumatoid arthritis; systemic juvenile idiopathic arthritis (SJIA); polyarticular juvenile idiopathic arthritis (PJIA); giant cell arteritis; and CAR T cell-induced severe or life-threatening cytokine release syndrome.

Briviact (brivaracetam)

Patient Population Altered: May 10, 2018
Date of Original Approval: February 19, 2016

Briviact (brivaracetam) is a selective, high-affinity synaptic vesicle protein 2A ligand and analog of levetiracetam indicated for the treatment of partial-onset seizures in patients with epilepsy.

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