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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.

Xtandi (enzalutamide) Capsules

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

New Indication Approved: July 13, 2018

Date of Original Approval: August 31, 2012 (Xtandi approval history)

Opdivo (nivolumab) Injection

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 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.

New Indication Approved: July 11, 2018

Date of Original Approval: December 22, 2014 (Opdivo approval history)

Xeomin (incobotulinumtoxinA) Injection

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

New Indication Approved: July 3, 2018

Date of Original Approval: July 30, 2010 (Xeomin approval history)

Nuplazid (pimavanserin) Tablets and Capsules

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

New Dosage Form Approved: June 29, 2018

Date of Original Approval: April 29, 2016 (Nuplazid approval history)

Aristada (aripiprazole lauroxil) Injection

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.

New Dosage Form Approved: June 29, 2018

Date of Original Approval: October 5, 2015 (Aristada approval history)

Avastin (bevacizumab) Injection

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.

New Indication Approved: June 13, 2018

Date of Original Approval: February 26, 2004 (Avastin approval history)

Keytruda (pembrolizumab) for Injection

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.

New Indication Approved: June 13, 2018

Date of Original Approval: September 4, 2014 (Keytruda approval history)

Keytruda (pembrolizumab) for Injection

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.

New Indication Approved: June 12, 2018

Date of Original Approval: September 4, 2014 (Keytruda approval history)

Venclexta (venetoclax) Tablets

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.

New Indication Approved: June 8, 2018

Date of Original Approval: April 11, 2016 (Venclexta approval history)

Rituxan (rituximab) Injection for Intravenous Use

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.

New Indication Approved: June 7, 2018

Date of Original Approval: November 26, 1997

Mircera (epoetin beta-methoxy polyethylene glycol) Injection

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

Patient Population Altered: June 7, 2018

Date of Original Approval: November 14, 2007 (Mircera approval history)

Xeljanz (tofacitinib) Tablets

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.

New Indication Approved: May 30, 2018

Date of Original Approval: November 6, 2012 (Xeljanz approval history)

Cimzia (certolizumab pegol) Injection

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.

New Indication Approved: May 25, 2018

Date of Original Approval: April 22, 2008 (Cimzia approval history)

Prolia (denosumab) Injection

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.

New Indication Approved: May 18, 2018

Date of Original Approval: June 1, 2010 (Prolia approval history)

Arnuity Ellipta (fluticasone furoate) Inhalation Powder

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

Patient Population Altered: May 17, 2018

Date of Original Approval: August 20, 2014 (Arnuity Ellipta approval history)

Taltz (ixekizumab) Injection

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

New Indication Approved: May 17, 2018

Date of Original Approval: March 22, 2016 (Taltz approval history)

Truvada (emtricitabine and tenofovir) Tablets

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.

Patient Population Altered: May 15, 2018

Date of Original Approval: August 2, 2004 (Truvada approval history)

Gilenya (fingolimod) Capsules

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

Patient Population Altered: May 11, 2018

Date of Original Approval: September 21, 2010 (Gilenya approval history)

Actemra (tocilizumab) Injection

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.

New Dosage Regimen: May 11, 2018

Date of Original Approval: January 8, 2010 (Actemra approval history)

Briviact (brivaracetam)

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.

Patient Population Altered: May 10, 2018

Date of Original Approval: February 19, 2016 (Briviact approval history)

Darzalex (daratumumab) Injection

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

New Indication Approved: May 7, 2018

Date of Original Approval: November 16, 2015 (Darzalex approval history)

Tafinlar (dabrafenib) Capsules

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.

New Indication Approved: May 4, 2018

Date of Original Approval: May 29, 2013 (Tafinlar approval history)

Kymriah (tisagenlecleucel) Suspension for Intravenous Infusion

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.

New Indication Approved: May 1, 2018

Date of Original Approval: August 30, 2017 (Kymriah approval history)

Tafinlar (dabrafenib) Capsules

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.

New Indication Approved: April 30, 2018

Date of Original Approval: May 29, 2013 (Tafinlar approval history)

Myrbetriq (mirabegron) Extended Release Tablets

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.

New Indication Approved: April 27, 2018

Date of Original Approval: June 28, 2012 (Myrbetriq approval history)

Tagrisso (osimertinib) Tablets

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.

New Indication Approved: April 18, 2018

Date of Original Approval: November 13, 2015 (Tagrisso approval history)

Opdivo (nivolumab) Injection

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 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.

New Indication Approved: April 16, 2018

Date of Original Approval: December 22, 2014 (Opdivo approval history)

Vonvendi (von willebrand factor (recombinant)) for Injection

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.

New Indication Approved: April 13, 2018

Date of Original Approval: December 8, 2015 (Vonvendi approval history)

Praxbind (idarucizumab) Injection

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

Labeling Revision Approved: April 12, 2018

Date of Original Approval: October 16, 2015 (Praxbind approval history)

Afinitor (everolimus) Tablets

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.

New Indication Approved: April 10, 2018

Date of Original Approval: March 30, 2009 (Afinitor approval history)

Rubraca (rucaparib) Tablets

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.

New Indication Approved: April 6, 2018

Date of Original Approval: December 19, 2016 (Rubraca approval history)

Exparel (bupivacaine liposome) Injectable Suspension

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.

New Indication Approved: April 6, 2018

Date of Original Approval: October 28, 2011 (Exparel approval history)

Bydureon (exenatide) Extended-Release Injectable Suspension

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

Labeling Revision Approved: April 2, 2018

Date of Original Approval: January 27, 2012 (Bydureon approval history)

Blincyto (blinatumomab) Injection

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.

New Indication Approved: March 29, 2018

Date of Original Approval: December 3, 2014 (Blincyto approval history)

Toujeo SoloStar (insulin glargine [rDNA origin]) Injection

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.

New Formulation Approved: March 26, 2018

Date of Original Approval: February 25, 2015 (Toujeo SoloStar approval history)

Tasigna (nilotinib) Capsules

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

Patient Population Altered: March 22, 2018

Date of Original Approval: October 29, 2007 (Tasigna approval history)

Adcetris (brentuximab vedotin) Injection

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.

New Indication Approved: March 20, 2018

Date of Original Approval: August 19, 2011 (Adcetris approval history)

Lucentis (ranibizumab) Injection

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.

New Dosage Form Approved: March 20, 2018

Date of Original Approval: June 30, 2006 (Lucentis approval history)

Hizentra (immune globulin subcutaneous (human)) Liquid

Hizentra (immune globulin subcutaneous (human)) is an immune globulin indicated for the treatment of primary immunodeficiency, and for the maintenance treatment of chronic inflammatory demyelinating polyneuropathy.

New Indication Approved: March 15, 2018

Date of Original Approval: March 4, 2010 (Hizentra approval history)

Opdivo (nivolumab) Injection

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 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.

New Dosage Regimen: March 5, 2018

Date of Original Approval: December 22, 2014 (Opdivo approval history)

Latuda (lurasidone) Tablets

Latuda (lurasidone) is an atypical antipsychotic agent for the treatment of schizophrenia and bipolar depression.

Patient Population Altered: March 5, 2018

Date of Original Approval: October 28, 2010 (Latuda approval history)

Otiprio (ciprofloxacin) Otic Suspension

Otiprio (ciprofloxacin otic suspension) is a single-dose, physician-administered, sustained-exposure otic fluoroquinolone antibacterial for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement surgery, and for the treatment of acute otitis externa due to Pseudomonas aeruginosa and Staphylococcus aureus.

New Indication Approved: March 2, 2018

Date of Original Approval: December 10, 2015 (Otiprio approval history)

Verzenio (abemaciclib) Tablets

Verzenio (abemaciclib) is a selective ATP-competitive inhibitor of cyclin dependent kinases (CDK) 4 and 6 indicated for the treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer.

New Indication Approved: February 26, 2018

Date of Original Approval: September 28, 2017 (Verzenio approval history)

Luzu (luliconazole) Topical Cream

Luzu (luliconazole) Cream is an azole antifungal indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis.

Patient Population Altered: February 20, 2018

Date of Original Approval: November 14, 2013 (Luzu approval history)

Imfinzi (durvalumab) Injection

Imfinzi (durvalumab) is an anti-PD-L1 (programmed death ligand-1) human monoclonal antibody for the treatment of patients with metastatic urothelial carcinoma and for the treatment of patients with unresectable non-small cell lung cancer that has not progressed after chemoradiation.

New Indication Approved: February 16, 2018

Date of Original Approval: May 1, 2017 (Imfinzi approval history)

Makena (hydroxyprogesterone caproate) Injection

Makena (hydroxyprogesterone caproate) is a long acting form of natural progesterone for the prevention of preterm birth in pregnant women.

New Dosage Form Approved: February 14, 2018

Date of Original Approval: February 3, 2011 (Makena approval history)

Zytiga (abiraterone) Tablets

Zytiga (abiraterone acetate) is a CYP17 inhibitor indicated for the treatment of patients with metastatic castration-resistant prostate cancer and metastatic high-risk castration-sensitive prostate cancer.

New Indication Approved: February 7, 2018

Date of Original Approval: April 28, 2011 (Zytiga approval history)

Feraheme (ferumoxytol) Intravenous Injection

Feraheme (ferumoxytol) is an iron replacement therapy for the treatment of iron deficiency anemia in adult patients.

New Indication Approved: February 2, 2018

Date of Original Approval: June 30, 2009 (Feraheme approval history)

Avycaz (avibactam and ceftazidime) Injection

Avycaz (avibactam and ceftazidime) is a next generation, non-β lactam β-lactamase inhibitor and third-generation, antipseudomonal cephalosporin antibiotic combination for the treatment of complicated intra-abdominal infections, complicated urinary tract infections, hospital-acquired bacterial pneumonia, and ventilator-associated bacterial pneumonia.

New Indication Approved: February 1, 2018

Date of Original Approval: February 25, 2015 (Avycaz approval history)

Trulance (plecanatide) Tablets

Trulance (plecanatide) is a guanylate cyclase-C agonist for the treatment of chronic idiopathic constipation, and irritable bowel syndrome with constipation (IBS-C).

New Indication Approved: January 25, 2018

Date of Original Approval: January 19, 2017 (Trulance approval history)

See also: New Drug Approvals, New Drug Applications, Recent Additions to Drugs.com