New Indications & Dosage Forms for Existing Drugs

Tecentriq (atezolizumab) Injection

New Indication Approved: March 18, 2019
Date of Original Approval: May 18, 2016

Tecentriq (atezolizumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of advanced urothelial carcinoma; the treatment of metastatic non-small cell lung cancer (NSCLC); and for use in combination with Abraxane for the treatment of metastatic triple-negative breast cancer.

• FDA Approves Genentech’s Tecentriq in Combination With Chemotherapy for the Initial Treatment of Adults With Extensive-Stage Small Cell Lung Cancer
• Tecentriq approval history

Avycaz (avibactam and ceftazidime) Injection

Patient Population Altered: March 14, 2019
Date of Original Approval: February 25, 2015

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.

• Allergan Announces FDA Approval of Avycaz (ceftazidime and avibactam) for Pediatric Patients
• Avycaz approval history

Dupixent (dupilumab) Injection

Patient Population Altered: March 11, 2019
Date of Original Approval: March 28, 2017

Dupixent (dupilumab) is an interleukin-4 receptor alpha antagonist indicated for the treatment of moderate-to-severe atopic dermatitis, and as an add-on maintenance treatment for moderate-to-severe asthma.

• FDA Approves Dupixent (dupilumab) for Moderate-to-Severe Atopic Dermatitis in Adolescents
• Dupixent approval history

Tecentriq (atezolizumab) Injection

New Indication Approved: March 8, 2019
Date of Original Approval: May 18, 2016

Tecentriq (atezolizumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of advanced urothelial carcinoma; the treatment of metastatic non-small cell lung cancer (NSCLC); and for use in combination with Abraxane for the treatment of metastatic triple-negative breast cancer.

• FDA Grants Genentech’s Tecentriq in Combination With Abraxane Accelerated Approval for People With PD-L1-Positive, Metastatic Triple-Negative Breast Cancer
• Tecentriq approval history

Soliqua 100/33 (insulin glargine and lixisenatide) Injection

New Indication Approved: February 27, 2019
Date of Original Approval: November 21, 2016

Soliqua 100/33 (insulin glargine and lixisenatide) is fixed-ratio combination of the long-acting human insulin analog insulin glargine (Lantus) and the glucagon-like peptide-1 (GLP-1) receptor agonist lixisenatide (Adlyxin), indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

• FDA Expands Indication for Soliqua 100/33 (insulin glargine and lixisenatide injection) to Include Type 2 Diabetes Patients Uncontrolled on Oral Antidiabetic Medicines
• Soliqua 100/33 approval history

Cinvanti (aprepitant) Injection

New Dosage Regimen: February 26, 2019
Date of Original Approval: November 9, 2017

Cinvanti (aprepitant) is a polysorbate 80 free, intravenous formulation of aprepitant, a substance P/neurokinin-1 (NK 1) receptor antagonist indicated for the prevention of chemotherapy-induced nausea and vomiting (CINV).

• FDA Approves Supplemental New Drug Application to Expand Cinvanti (aprepitant) Label for IV Push
• Cinvanti approval history

Lonsurf (tipiracil hydrochloride and trifluridine) Capsules

New Indication Approved: February 22, 2019
Date of Original Approval: September 22, 2015

Lonsurf (tipiracil and trifluridine) is a thymidine phosphorylase inhibitor and nucleoside metabolic inhibitor combination indicated for the treatment of patients with previously treated metastatic colorectal cancer, and previously treated metastatic gastric or gastroesophageal junction adenocarcinoma.

• FDA Approves Lonsurf (trifluridine/tipiracil) for Adult Patients with Previously Treated Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
• Lonsurf approval history

Keytruda (pembrolizumab) for Injection

New Indication Approved: February 15, 2019
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, hepatocellular carcinoma, and Merkel cell carcinoma.

• FDA Approves Keytruda (pembrolizumab) for the Adjuvant Treatment of Patients with Melanoma with Involvement of Lymph Node(s) Following Complete Resection
• Keytruda approval history

Darzalex (daratumumab) Injection

New Dosage Regimen: February 8, 2019
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.

• FDA Approves Darzalex (daratumumab) Split-Dosing Regimen
• Darzalex approval history

Tremfya (guselkumab) Injection

New Dosage Regimen: January 29, 2019
Date of Original Approval: July 13, 2017

Tremfya (guselkumab) is an interleukin-23 blocker indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

• FDA Approves Tremfya (guselkumab) One-Press Patient-Controlled Injector for Adults with Moderate-to-Severe Plaque Psoriasis
• Tremfya approval history

Imbruvica (ibrutinib) Capsules and Tablets

New Dosage Regimen: January 28, 2019
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 Obinutuzumab as First Non-Chemotherapy Combination Regimen for Treatment-Naïve Patients with Chronic Lymphocytic Leukemia
• Imbruvica approval history

Osphena (ospemifene) Tablets

New Indication Approved: January 25, 2019
Date of Original Approval: February 26, 2013

Osphena (ospemifene) is an estrogen agonist/antagonist indicated for the treatment of symptoms of vulvar and vaginal atrophy due to menopause, including severe dyspareunia and moderate to severe vaginal dryness.

• FDA Approves Osphena (ospemifene) for Moderate to Severe Vaginal Dryness Due to Menopause
• Osphena approval history

Fluzone Quadrivalent (influenza virus vaccine, inactivated) Suspension for Intramuscular Injection

New Dosage Regimen: January 23, 2019
Date of Original Approval: June 7, 2013

Fluzone Quadrivalent is an inactivated influenza virus vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

• FDA Approves Use of 0.5 mL Dose of Fluzone Quadrivalent (influenza vaccine) in Children as Young as 6 Months of Age
• Fluzone Quadrivalent approval history

Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap))

New Dosage Regimen: January 14, 2019
Date of Original Approval: June 10, 2005

Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap)) is indicated for active booster immunization for the prevention of tetanus, diphtheria and pertussis.

• FDA Approves Expanded Use of Adacel (Tdap) Vaccine for Repeat Vaccination
• Adacel approval history

Cabometyx (cabozantinib) Tablets

New Indication Approved: January 14, 2019
Date of Original Approval: April 25, 2016

Cabometyx (cabozantinib) is a tyrosine kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC), and patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

• Exelixis Announces U.S. FDA Approval of Cabometyx (cabozantinib) Tablets for Previously Treated Hepatocellular Carcinoma
• Cabometyx approval history

Apadaz (acetaminophen and benzhydrocodone hydrochloride) Tablets

New Dosage Regimen: January 7, 2019
Date of Original Approval: February 23, 2018

Apadaz (acetaminophen and benzhydrocodone hydrochloride) is an immediate release combination of acetaminophen and benzhydrocodone, a prodrug of the opioid agonist hydrocodone, indicated for the short-term management of acute pain.

• KemPharm Announces FDA Approval of sNDA for Two Additional Strengths of Apadaz (4.08 mg benzhydrocodone/325 mg APAP and 8.16 mg benzhydrocodone/325 mg APAP)
• Apadaz approval history

Ravicti (glycerol phenylbutyrate) Oral Liquid

Patient Population Altered: December 21, 2018
Date of Original Approval: February 1, 2013

Ravicti (glycerol phenylbutyrate) is a nitrogen-binding agent for the chronic management of patients with urea cycle disorders.

• Horizon Pharma plc Announces FDA Approval to Expand the Age Range for Ravicti (glycerol phenylbutyrate) Oral Liquid to Include Newborns
• Ravicti approval history

Sprycel (dasatinib) Tablets

Patient Population Altered: December 21, 2018
Date of Original Approval: June 28, 2006

Sprycel (dasatinib) is a kinase inhibitor indicated for the treatment of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia.

• Sprycel (dasatinib) Tablets Now Approved in Combination with Chemotherapy in Certain Pediatric Patients with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
• Sprycel approval history

Lynparza (olaparib) Tablets

New Indication Approved: December 19, 2018
Date of Original Approval: December 19, 2014

Lynparza (olaparib) is a first-in-class oral poly ADP ribose polymerase (PARP) inhibitor for the treatment of BRCA-mutated, advanced ovarian cancer; for the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer; and for the treatment of germline BRCA-mutated metastatic breast cancer.

• Lynparza (olaparib) Approved by US FDA for First-Line Maintenance Therapy in BRCA-Mutated Advanced Ovarian Cancer
• Lynparza approval history

Keytruda (pembrolizumab) for Injection

New Indication Approved: December 19, 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, hepatocellular carcinoma, and Merkel cell carcinoma.

• FDA Approves Keytruda (pembrolizumab) for the Treatment of Patients with Recurrent Locally Advanced or Metastatic Merkel Cell Carcinoma
• Keytruda approval history

Envarsus XR (tacrolimus) Extended-Release Tablets

New Indication Approved: December 19, 2018
Date of Original Approval: July 10, 2015

Envarsus XR (tacrolimus) is a once-daily extended-release immunosuppressant for the prophylaxis of organ rejection in kidney transplant patients.

• FDA Approves New Indication for Envarsus XR (tacrolimus extended-release tablets)
• Envarsus XR approval history

Nplate (romiplostim)

Patient Population Altered: December 14, 2018
Date of Original Approval: August 22, 2008

Nplate (romiplostim) is a thrombopoietin mimetic peptibody for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP).

• FDA Approves Nplate (Romiplostim) For Use In Pediatric Patients With Immune Thrombocytopenia
• Nplate approval history

Tecentriq (atezolizumab) Injection

New Indication Approved: December 6, 2018
Date of Original Approval: May 18, 2016

Tecentriq (atezolizumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of advanced urothelial carcinoma; the treatment of metastatic non-small cell lung cancer (NSCLC); and for use in combination with Abraxane for the treatment of metastatic triple-negative breast cancer.

• FDA Approves Genentech’s Tecentriq in Combination With Avastin and Chemotherapy for the Initial Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer
• Tecentriq approval history

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 adult patients with:

• Previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine.
• Classical Hodgkin lymphoma (cHL) at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation.
• Classical Hodgkin lymphoma (cHL) after failure of auto-HSCT or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates.
• Previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone.
• Systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen.
• Primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30- expressing mycosis fungoides (MF) who have received prior systemic therapy.

• 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, hepatocellular carcinoma, and Merkel cell 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, hepatocellular carcinoma, and Merkel cell 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 moderate-to-severe atopic dermatitis, and as an add-on maintenance treatment for 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, hepatocellular carcinoma, and Merkel cell 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