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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.

Fragmin (dalteparin sodium) Injection

Patient Population Altered: May 16, 2019
Date of Original Approval: December 22, 1994

Fragmin (dalteparin sodium) is a low molecular weight heparin (LMWH) indicated for:

  • Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction
  • Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery or medical patients with severely restricted mobility during acute illness
  • Extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in adult patients with cancer. In these patients, the Fragmin therapy begins with the initial VTE treatment and continues for six months
  • Treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in pediatric patients 1 month of age and older

Gattex (teduglutide) for Injection

Patient Population Altered: May 16, 2019
Date of Original Approval: December 21, 2012

Gattex (teduglutide) is a recombinant analog of human glucagon-like peptide 2 for the treatment of short bowel syndrome in adults and pediatric patients one year of age and older.

Venclexta (venetoclax) Tablets

New Indication Approved: May 15, 2019
Date of Original Approval: April 11, 2016

Venclexta (venetoclax) is an oral B-cell lymphoma-2 (BCL-2) inhibitor indicated:

  • for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
  • in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

Bavencio (avelumab) Injection

New Indication Approved: May 14, 2019
Date of Original Approval: March 23, 2017

Bavencio (avelumab) is a programmed death ligand-1 (PD-L1) blocking antibody indicated for the treatment of patients with metastatic Merkel cell carcinoma (MCC); patients with advanced or metastatic urothelial carcinoma; and in combination with axitinib for patients with advanced renal cell carcinoma.

Eylea (aflibercept) Injection

New Indication Approved: May 13, 2019
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.

Cyramza (ramucirumab) Injection

New Indication Approved: May 10, 2019
Date of Original Approval: April 21, 2014

Cyramza (ramucirumab) is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated:

  • as a single agent or in combination with paclitaxel, for treatment of advanced or metastatic gastric cancer or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.
  • in combination with docetaxel, for treatment of metastatic non-small cell lung cancer with disease progression on or after platinum-based chemotherapy.
  • in combination with FOLFIRI, for the treatment of metastatic colorectal cancer with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.
  • as a single agent, for the treatment of hepatocellular carcinoma in patients who have an alpha fetoprotein of ≥400 ng/mL and have been treated with sorafenib.

Xeomin (incobotulinumtoxinA) Injection

New Indication Approved: May 10, 2019
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.

Kadcyla (ado-trastuzumab emtansine) Injection

New Indication Approved: May 3, 2019
Date of Original Approval: February 22, 2013

Kadcyla (ado-trastuzumab emtansine) is a HER2-targeted antibody and microtubule inhibitor conjugate indicated for the treatment of patients with HER2-positive, metastatic breast cancer.

Tibsovo (ivosidenib) Tablets

New Indication Approved: May 2, 2019
Date of Original Approval: July 20, 2018

Tibsovo (ivosidenib) is an isocitrate dehydrogenase-1 (IDH1) inhibitor for the treatment of patients with acute myeloid leukemia who have an IDH1 mutation.

Mavyret (glecaprevir and pibrentasvir) Tablets

Patient Population Altered: April 30, 2019
Date of Original Approval: August 3, 2017

Mavyret (glecaprevir/pibrentasvir) is a fixed-dose combination of glecaprevir, an NS3/4A protease inhibitor, and pibrentasvir, an NS5A inhibitor, indicated for the treatment of all major genotypes (GT1-6) of chronic hepatitis C.

Kalydeco (ivacaftor) Tablets and Oral Granules

Patient Population Altered: April 29, 2019
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 6 months and older who have one mutation in the CFTR gene that is responsive to ivacaftor.

Benlysta (belimumab) Injection

Patient Population Altered: April 26, 2019
Date of Original Approval: March 10, 2011

Benlysta (belimumab) is B-lymphocyte stimulator (BLyS)-specific inhibitor indicated for the treatment of patients with systemic lupus erythematosus.

Praluent (alirocumab) Injection

New Indication Approved: April 26, 2019
Date of Original Approval: July 24, 2015

Praluent (alirocumab) is a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor monoclonal antibody indicated:

  • as an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for the treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce low-density lipoprotein cholesterol LDL-C.
  • to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.

Keytruda (pembrolizumab) for Injection

New Indication Approved: April 19, 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, Merkel cell carcinoma, and renal cell carcinoma.

Keytruda (pembrolizumab) for Injection

New Indication Approved: April 11, 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, Merkel cell carcinoma, and renal cell carcinoma.

Ibrance (palbociclib) Capsules

New Indication Approved: April 4, 2019
Date of Original Approval: February 3, 2015

Ibrance (palbociclib) is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor for the combination treatment of ER+, HER2- metastatic breast cancer.

Zelnorm (tegaserod) Tablets

New Indication Approved: March 29, 2019
Date of Original Approval: July 24, 2002

Zelnorm (tegaserod) is a serotonin-4 (5-HT4) receptor agonist indicated for the treatment of adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C)

Cimzia (certolizumab pegol) Injection

New Indication Approved: March 28, 2019
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, plaque psoriasis, and non-radiographic axial spondyloarthritis.

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); extensive-stage small cell lung cancer; and for use in combination with Abraxane for the treatment of metastatic triple-negative breast cancer.

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.

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.

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); extensive-stage small cell lung cancer; and for use in combination with Abraxane for the treatment of metastatic triple-negative breast cancer.

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.

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).

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.

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, Merkel cell carcinoma, and renal cell carcinoma.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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, Merkel cell carcinoma, and renal cell carcinoma.

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.

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).

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); extensive-stage small cell lung cancer; and for use in combination with Abraxane for the treatment of metastatic triple-negative breast cancer.

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 indicated:

  • for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
  • in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

Actemra (tocilizumab) Injection

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

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

Adcetris (brentuximab vedotin) Injection

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

Adcetris (brentuximab vedotin) is a CD30-directed antibody-drug conjugate (ADC) indicated for the treatment of 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.

Promacta (eltrombopag) Tablets

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

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

Keytruda (pembrolizumab) for Injection

New Indication Approved: November 9, 2018
Date of Original Approval: September 4, 2014

Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody indicated for the treatment of melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, and renal cell carcinoma.

Empliciti (elotuzumab) Injection

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

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

Keytruda (pembrolizumab) for Injection

New Indication Approved: October 30, 2018
Date of Original Approval: September 4, 2014

Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody indicated for the treatment of melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, and renal cell carcinoma.

Invokana (canagliflozin) Tablets

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

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

Dupixent (dupilumab) Injection

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

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

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