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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.

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, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, cervical cancer, and primary mediastinal large B-cell lymphoma.

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, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, cervical cancer, and primary mediastinal large B-cell lymphoma.

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, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, cervical cancer, and primary mediastinal large B-cell lymphoma.

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 patients with chronic lymphocytic leukemia (CLL) with 17p deletion.

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.

Darzalex (daratumumab) Injection

New Indication Approved: May 7, 2018
Date of Original Approval: November 16, 2015

Darzalex (daratumumab) is a human anti-CD38 monoclonal antibody indicated for the treatment of patients with multiple myeloma.

Tafinlar (dabrafenib) Capsules

New Indication Approved: May 4, 2018
Date of Original Approval: May 29, 2013

Tafinlar (dabrafenib) is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.

Tafinlar is also indicated, in combination with trametinib (Mekinist), for:

  • the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.
  • the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection.
  • the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test.
  • the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options.

Kymriah (tisagenlecleucel) Suspension for Intravenous Infusion

New Indication Approved: May 1, 2018
Date of Original Approval: August 30, 2017

Kymriah (tisagenlecleucel) is a chimeric antigen receptor T cell (CAR-T) therapy for use in patients with relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (ALL) and patients with relapsed or refractory (r/r) large B-cell lymphoma.

Tafinlar (dabrafenib) Capsules

New Indication Approved: April 30, 2018
Date of Original Approval: May 29, 2013

Tafinlar (dabrafenib) is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.

Tafinlar is also indicated, in combination with trametinib (Mekinist), for:

  • the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.
  • the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection.
  • the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test.
  • the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options.

Myrbetriq (mirabegron) Extended Release Tablets

New Indication Approved: April 27, 2018
Date of Original Approval: June 28, 2012

Myrbetriq (mirabegron) is a beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Tagrisso (osimertinib) Tablets

New Indication Approved: April 18, 2018
Date of Original Approval: November 13, 2015

Tagrisso (osimertinib) is a tyrosine kinase inhibitor (TKI) of epidermal growth factor receptor (EGFR) indicated for the treatment of patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer.

Opdivo (nivolumab) Injection

New Indication Approved: April 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.

Vonvendi (von willebrand factor (recombinant)) for Injection

New Indication Approved: April 13, 2018
Date of Original Approval: December 8, 2015

Vonvendi [von Willebrand factor (recombinant)] is a recombinant von Willebrand factor (VWF) indicated for on-demand treatment and control of bleeding episodes in adults diagnosed with von Willebrand disease.

Praxbind (idarucizumab) Injection

Labeling Revision Approved: April 12, 2018
Date of Original Approval: October 16, 2015

Praxbind (idarucizumab) is a humanized monoclonal antibody fragment (Fab) indicated as a specific reversal agent for the anticoagulant effect of dabigatran (Pradaxa).

Afinitor (everolimus) Tablets

New Indication Approved: April 10, 2018
Date of Original Approval: March 30, 2009

Afinitor (everolimus) is an oral once-daily inhibitor of mTOR indicated for the treatment of patients with advanced HR+, HER2- breast cancer; progressive neuroendocrine tumors of pancreatic origin (PNET); progressive neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin; advanced renal cell carcinoma; and subependymal giant cell astrocytoma (SEGA) and renal angiomyolipomas associated with tuberous sclerosis.

Rubraca (rucaparib) Tablets

New Indication Approved: April 6, 2018
Date of Original Approval: December 19, 2016

Rubraca (rucaparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of patients with deleterious BRCA mutation (germline and/or somatic)-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies; and for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Exparel (bupivacaine liposome) Injectable Suspension

New Indication Approved: April 6, 2018
Date of Original Approval: October 28, 2011

Exparel (bupivacaine liposome injectable suspension) is a long-acting non-opioid local analgesic for postsurgical local analgesia, and for use as a nerve block (interscalene brachial plexus block) to provide pain relief following shoulder surgeries.

Bydureon (exenatide) Extended-Release Injectable Suspension

Labeling Revision Approved: April 2, 2018
Date of Original Approval: January 27, 2012

Bydureon (exenatide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve glycemic control in patients with type 2 diabetes.

Blincyto (blinatumomab) Injection

New Indication Approved: March 29, 2018
Date of Original Approval: December 3, 2014

Blincyto (blinatumomab) is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), and minimal residual disease (MRD)-positive B-cell precursor ALL.

Toujeo SoloStar (insulin glargine [rDNA origin]) Injection

New Formulation Approved: March 26, 2018
Date of Original Approval: February 25, 2015

Toujeo SoloStar (insulin glargine [rDNA origin] is a once-daily long-acting basal insulin used to improve glycemic control in adults with type 1 and type 2 diabetes.

Tasigna (nilotinib) Capsules

Patient Population Altered: March 22, 2018
Date of Original Approval: October 29, 2007

Tasigna (nilotinib) is a kinase inhibitor indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (CML).

Adcetris (brentuximab vedotin) Injection

New Indication Approved: March 20, 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.

Lucentis (ranibizumab) Injection

New Dosage Form Approved: March 20, 2018
Date of Original Approval: June 30, 2006

Lucentis (ranibizumab) is a humanized anti-VEGF antibody fragment indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization.

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