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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.

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.

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); 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, and Merkel 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, and Merkel 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); 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 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.

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, and Merkel 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, and Merkel 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.

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.

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)

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.

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.

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.

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.

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.

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.

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.

Actemra (tocilizumab) Injection

New Dosage Regimen: September 12, 2018
Date of Original Approval: January 8, 2010

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

Imbruvica (ibrutinib) Capsules and Tablets

New Indication Approved: August 24, 2018
Date of Original Approval: November 13, 2013

Imbruvica (ibrutinib) is an oral Bruton's tyrosine kinase (BTK) inhibitor for the treatment of mantle cell lymphoma, chronic lymphocytic leukemia, Waldenström’s macroglobulinemia, small lymphocytic lymphoma, marginal zone lymphoma, and chronic graft versus host disease.

Keytruda (pembrolizumab) for Injection

Labeling Revision Approved: August 20, 2018
Date of Original Approval: September 4, 2014

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

Opdivo (nivolumab) Injection

New Indication Approved: August 16, 2018
Date of Original Approval: December 22, 2014

Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of advanced melanoma, advanced non-small cell lung cancer, advanced small cell lung cancer, advanced renal cell carcinoma, classical Hodgkin lymphoma, advanced squamous cell carcinoma of the head and neck, urothelial carcinoma, MSI-H or dMMR metastatic colorectal cancer, and hepatocellular carcinoma.

Eylea (aflibercept) Injection

New Dosage Regimen: August 16, 2018
Date of Original Approval: November 18, 2011

Eylea (aflibercept) is a VEGF inhibitor indicated for the treatment of patients with neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.

Lenvima (lenvatinib) Capsules

New Indication Approved: August 15, 2018
Date of Original Approval: February 13, 2015

Lenvima (lenvatinib) is a multiple receptor tyrosine kinase (RTK) inhibitor for the treatment of progressive radioiodine-refractory differentiated thyroid cancer, advanced renal cell carcinoma, and hepatocellular carcinoma.

Kalydeco (ivacaftor) Tablets and Oral Granules

Patient Population Altered: August 15, 2018
Date of Original Approval: January 31, 2012

Kalydeco (ivacaftor) is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator indicated for the treatment of cystic fibrosis (CF) in patients ages one year and older who have one mutation in the CFTR gene that is responsive to ivacaftor.

Orkambi (ivacaftor and lumacaftor) Tablets and Oral Granules

New Dosage Form Approved: August 7, 2018
Date of Original Approval: July 2, 2015

Orkambi (ivacaftor and lumacaftor) is a CFTR potentiator and CFTR corrector combination for the treatment of the underlying cause of cystic fibrosis in patients 2 years and older with two copies of the F508del mutation in their CFTR gene.

Granix (tbo-filgrastim) Injection

New Indication Approved: July 31, 2018
Date of Original Approval: August 29, 2012

Granix (tbo-filgrastim) is a leukocyte growth factor indicated for the reduction in the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs.

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