New Indications & Dosage Forms for Existing Drugs

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.

• Genentech Announces FDA Grants Venclexta Accelerated Approval for People With Newly-Diagnosed Acute Myeloid Leukemia or Those Who Are Ineligible For Intensive Induction Chemotherapy
• Venclexta approval history

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.

• FDA Approves The ACTpen for Actemra, A Single-Dose, Prefilled Autoinjector
• Actemra approval history

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.

• FDA Approves Adcetris (brentuximab vedotin) in Combination with Chemotherapy for Adults with Previously Untreated Systemic Anaplastic Large Cell Lymphoma or Other CD30-Expressing Peripheral T-Cell Lymphomas
• Adcetris approval history

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.

• FDA Approves Promacta (eltrombopag) for First-Line Severe Aplastic Anemia
• Promacta approval history

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.

• FDA Approves Keytruda (pembrolizumab) for the Treatment of Patients with Hepatocellular Carcinoma (HCC) Who Have Been Previously Treated with Sorafenib
• Keytruda approval history

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.

• FDA Approves Empliciti (elotuzumab) Plus Pomalidomide and Dexamethasone, a New Immunotherapy Combination for Certain Patients with Relapsed or Refractory Multiple Myeloma
• Empliciti approval history

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.

• FDA Approves Keytruda (pembrolizumab) in Combination with Carboplatin and Either Paclitaxel or Nab-Paclitaxel for the First-Line Treatment of Patients with Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)
• Keytruda approval history

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.

• FDA Approves Invokana (canagliflozin) to Reduce the Risk of Heart Attack, Stroke or Cardiovascular Death in Adults with Type 2 Diabetes and Established Cardiovascular Disease
• Invokana approval history

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.

• FDA Approves Dupixent (dupilumab) for Moderate-to-Severe Asthma
• Dupixent approval history

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.

• FDA Approves Liletta (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Five Years
• Liletta approval history

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)

• FDA Approves Xarelto to Reduce the Risk of Major Cardiovascular Events in Patients with Chronic Coronary Artery Disease (CAD) or Peripheral Artery Disease (PAD)
• Xarelto approval history

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.

• FDA Approves Expanded Use of Gardasil 9 to Include Individuals 27 Through 45 Years Old
• Gardasil 9 approval history

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.

• FDA Approves Genentech’s Hemlibra (emicizumab-kxwh) for Hemophilia A Without Factor VIII Inhibitors
• Hemlibra approval history

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.

• FDA Approves Accelerated 7-Day Vaccine Dosing Schedule for Ixiaro
• Ixiaro approval history

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.

• FDA Approves Genentech's Xolair (omalizumab) Prefilled Syringe Formulation

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.

• FDA Approves Fycompa for the Treatment of Partial-Onset Seizures in Pediatric Patients as Young as 4 Years Old
• Fycompa approval history

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.

• FDA Approves Kyprolis (carfilzomib) Once-Weekly Kd70 Regimen for Relapsed or Refractory Multiple Myeloma
• Kyprolis approval history

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.

• Adamis Pharmaceuticals Receives FDA Approval for Its Lower Dose Symjepi Product
• Symjepi approval history

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.

• FDA Approves Subcutaneous Formulation of Actemra for Use in Active Systemic Juvenile Idiopathic Arthritis (SJIA)
• Actemra approval history

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.

• FDA Approves Imbruvica (ibrutinib) Plus Rituximab for Patients with Waldenström’s Macroglobulinemia
• Imbruvica approval history

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.

• FDA Approves Expanded Label for Merck’s Keytruda (pembrolizumab) in Patients with Metastatic Nonsquamous NSCLC with No EGFR or ALK Genomic Tumor Aberrations
• Keytruda approval history

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.

• FDA Approves Opdivo (nivolumab) for Certain Patients with Previously Treated Small Cell Lung Cancer
• Opdivo approval history

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.

• FDA Approves New Eylea (aflibercept) Injection Dosing Schedule in Wet Age-Related Macular Degeneration
• Eylea approval history

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.

• FDA Approves Lenvima (lenvatinib) for First-line Treatment of Unresectable Hepatocellular Carcinoma (HCC)
• Lenvima approval history

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.

• FDA Approves Kalydeco (ivacaftor) for Cystic Fibrosis in Children Ages 12 to <24 Months with Certain Mutations in the CFTR Gene
• Kalydeco approval history

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.

• FDA Approves Expanded Indication for Orkambi (lumacaftor/ivacaftor) in Children Ages 2-5 Years
• Orkambi approval history

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.

• Teva Announces Updated Indication and Vial Presentation for Granix (tbo-filgrastim) Injection in United States
• Granix approval history

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.

• United Therapeutics Announces FDA Approval of the Implantable System for Remodulin

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.

• Kisqali (ribociclib) Approved for Additional Indications in HR+/HER2- Advanced Breast Cancer
• Kisqali approval history

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.

• FDA Approves Xtandi (enzalutamide) for the Treatment of Men with Non-Metastatic Castration-Resistant Prostate Cancer (CRPC)
• Xtandi approval history

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.

• Opdivo (nivolumab) + Low-Dose Yervoy (ipilimumab) Combination Approved for Previously Treated MSI-H/dMMR Metastatic Colorectal Cancer
• Opdivo approval history

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.

• FDA Approves Xeomin (incobotulinumtoxinA) for Adult Patients with Sialorrhea (Excessive Drooling)
• Xeomin approval history

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.

• Acadia Pharmaceuticals Announces FDA Approval of New Dosing Formulation and Strength for Nuplazid (pimavanserin)
• Nuplazid approval history

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.

• FDA Approves Aristada Initio (aripiprazole lauroxil) for the Initiation of Aristada for Schizophrenia
• Aristada approval history

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).

• Shire Announces FDA Approval for Label Expansion of Cinryze (C1 esterase inhibitor [human]) for Prevention of Attacks in Pediatric Hereditary Angioedema Patients
• Cinryze approval history

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.

• FDA Approves Genentech’s Avastin (bevacizumab) Plus Chemotherapy as a Treatment for Women With Advanced Ovarian Cancer Following Initial Surgery
• Avastin approval history

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.

• FDA Approves Keytruda (pembrolizumab) for Treatment of Refractory or Relapsed Primary Mediastinal Large B-Cell Lymphoma (PMBCL)
• Keytruda approval history

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.

• FDA Approves Keytruda (pembrolizumab) for Previously Treated Patients with Recurrent or Metastatic Cervical Cancer Whose Tumors Express PD-L1
• Keytruda approval history

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.

• Genentech Announces FDA Approval for Venclexta Plus Rituxan for People With Previously Treated Chronic Lymphocytic Leukemia
• Venclexta approval history

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.

• FDA Approves Genentech’s Rituxan (rituximab) for Pemphigus Vulgaris
• Rituxan approval history

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.

• FDA Approves Mircera for Anemia Associated with Chronic Kidney Disease in Pediatric Patients on Dialysis
• Mircera approval history

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.

• Pfizer Announces U.S. FDA Approves Xeljanz (tofacitinib) for the Treatment of Moderately to Severely Active Ulcerative Colitis
• Xeljanz approval history

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.

• UCB Announces the Approval of Cimzia (certolizumab pegol) for Moderate-to-Severe Plaque Psoriasis
• Cimzia approval history

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.

• FDA Approves Prolia (denosumab) for Glucocorticoid-Induced Osteoporosis
• Prolia approval history

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.

• GSK Receives FDA Approval of Arnuity Ellipta for Asthma in Children From 5 Years of Age
• Arnuity Ellipta approval history

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.

• Lilly's Taltz (ixekizumab) Receives the First U.S. FDA Approval for Label Update to Include Data for Psoriasis Involving the Genital Area
• Taltz approval history

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.

• FDA Approves Expanded Indication for Truvada (emtricitabine and tenofovir disoproxil fumarate) for Reducing the Risk of Acquiring HIV-1 in Adolescents
• Truvada approval history

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.

• FDA Expands Approval of Gilenya (fingolimod) to Treat Multiple Sclerosis in Pediatric Patients
• Gilenya approval history

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.

• FDA Approves Subcutaneous Formulation of Actemra for use in Active Polyarticular Juvenile Idiopathic Arthritis
• Actemra approval history

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.

• UCB Announces Briviact (brivaracetam) Now Approved by FDA to Treat Partial-Onset (Focal) Seizures in Pediatric Epilepsy Patients
• Briviact approval history