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.
Blincyto (blinatumomab) Injection
Date of Approval: December 3, 2014
Blincyto (blinatumomab) is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
New Indication Approved: July 11, 2017
See approval history for Blincyto
Orencia (abatacept) Injection
Date of Approval: December 23, 2005
Orencia (abatacept) is a selective T cell costimulation modulator indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis and psoriatic arthritis.
New Indication Approved: June 30, 2017
See approval history for Orencia
Vectibix (panitumumab) Injection
Date of Approval: September 27, 2006
Vectibix (panitumumab) is an epidermal growth factor receptor (EGFR) antagonist indicated for the treatment of wild-type RAS (defined as wild-type in both KRAS and NRAS) metastatic colorectal cancer.
New Indication Approved: June 29, 2017
See approval history for Vectibix
Darzalex (daratumumab) Injection
Date of Approval: November 16, 2015
Darzalex (daratumumab) is a human anti-CD38 monoclonal antibody indicated for the treatment of patients with multiple myeloma.
New Indication Approved: June 16, 2017
See approval history for Darzalex
Dysport (abobotulinumtoxinA) Injection
Date of Approval: April 29, 2009
Dysport (abobotulinumtoxinA) is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the treatment of cervical dystonia, for the temporary improvement in the appearance of moderate to severe glabellar lines, for the treatment of spasticity in adults, and the treatment of lower limb spasticity in pediatric patients.
New Indication Approved: June 14, 2017
See approval history for Dysport
Aristada (aripiprazole lauroxil) Injection
Date of 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.
New Dosage Regimen: June 5, 2017
See approval history for Aristada
Isentress (raltegravir) Tablets
Date of Approval: October 12, 2007
Isentress (raltegravir) is a human immunodeficiency virus integrase strand transfer inhibitor (HIV-1 INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
New Dosage Form Approved: May 26, 2017
See approval history for Isentress
Zykadia (ceritinib) Capsules
Date of Approval: April 29, 2014
Zykadia (ceritinib) is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer.
New Indication Approved: May 26, 2017
See approval history for Zykadia
Keytruda (pembrolizumab) for Injection
Date of Approval: September 4, 2014
Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody indicated for the treatment of metastatic melanoma, metastatic non-small cell lung cancer, recurrent or metastatic head and neck squamous cell carcinoma, and classical Hodgkin lymphoma.
New Indication Approved: May 23, 2017
See approval history for Keytruda
Actemra (tocilizumab) Injection
Date of Approval: January 8, 2010
Actemra (tocilizumab) is a humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody for the treatment of moderate to severe rheumatoid arthritis in adults, and the treatment of active systemic juvenile idiopathic arthritis (SJIA) and polyarticular juvenile idiopathic arthritis (PJIA) in patients two years of age and older.
New Indication Approved: May 22, 2017
See approval history for Actemra
Keytruda (pembrolizumab) for Injection
Date of Approval: September 4, 2014
Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody indicated for the treatment of metastatic melanoma, metastatic non-small cell lung cancer, recurrent or metastatic head and neck squamous cell carcinoma, and classical Hodgkin lymphoma.
New Indication Approved: May 18, 2017
See approval history for Keytruda
Kalydeco (ivacaftor) Tablets
Date of 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 age 2 years and older who have the G551D or R117H mutations in the CFTR gene.
New Indication Approved: May 17, 2017
See approval history for Kalydeco
Keytruda (pembrolizumab) for Injection
Date of Approval: September 4, 2014
Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody indicated for the treatment of metastatic melanoma, metastatic non-small cell lung cancer, recurrent or metastatic head and neck squamous cell carcinoma, and classical Hodgkin lymphoma.
New Indication Approved: May 10, 2017
See approval history for Keytruda
Bavencio (avelumab) Injection
Date of 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) and urothelial carcinoma.
New Indication Approved: May 9, 2017
See approval history for Bavencio
Stivarga (regorafenib) Tablets
Date of Approval: September 27, 2012
Stivarga (regorafenib) is an oral multi-kinase inhibitor for the treatment of patients with metastatic colorectal cancer, gastrointestinal stromal tumors, and hepatocellular carcinoma.
New Indication Approved: April 27, 2017
See approval history for Stivarga
Praluent (alirocumab) Injection
Date of Approval: July 24, 2015
Praluent (alirocumab) is a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor monoclonal antibody for the treatment of patients with heterozygous familial hypercholesterolemia or atherosclerotic heart disease who require additional lowering of LDL-cholesterol.
New Dosage Regimen: April 24, 2017
See approval history for Praluent
Tecentriq (atezolizumab) Injection
Date of Approval: May 18, 2016
Tecentriq (atezolizumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of patients with advanced urothelial carcinoma and patients with metastatic non-small cell lung cancer (NSCLC).
New Indication Approved: April 17, 2017
See approval history for Tecentriq
Lucentis (ranibizumab) Injection
Date of Approval: June 30, 2006
Lucentis (ranibizumab) is a humanized anti-VEGF antibody fragment indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization.
New Indication Approved: April 15, 2017
See approval history for Lucentis
Harvoni (ledipasvir and sofosbuvir) Tablets
Date of Approval: October 10, 2014
Harvoni (ledipasvir and sofosbuvir) is a once-daily NS5A inhibitor and nucleotide analog polymerase inhibitor fixed-dose combination for the treatment of chronic hepatitis C virus (HCV) genotype 1, 4, 5 or 6 infection.
Patient Population Altered: April 7, 2017
See approval history for Harvoni
Sovaldi (sofosbuvir) Tablets
Date of Approval: December 6, 2013
Sovaldi (sofosbuvir) is a once-daily oral nucleotide analogue for the treatment of chronic hepatitis C virus (HCV) infection.
Patient Population Altered: April 7, 2017
See approval history for Sovaldi
Ibrance (palbociclib) Capsules
Date of 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.
Labeling Revision Approved: March 31, 2017
See approval history for Ibrance
Tagrisso (osimertinib) Tablets
Date of Approval: November 13, 2015
Tagrisso (osimertinib) is a tyrosine kinase inhibitor (TKI) of epidermal growth factor receptor (EGFR) indicated for the treatment of patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer whose disease has worsened on or after EGFR-TKI therapy.
Labeling Revision Approved: March 30, 2017
See approval history for Tagrisso
Qudexy XR (topiramate) Extended-Release Capsules
Date of Approval: March 11, 2014
Qudexy XR (topiramate) is an antiepileptic drug indicated for the treatment of partial onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut Syndrome in adults and children; and for the prophylaxis of migraine headache in adults and adolescents.
New Indication Approved: March 29, 2017
See approval history for Qudexy XR
Humira (adalimumab) Injection
Date of Approval: December 31, 2002
Humira (adalimumab) is a recombinant human IgGl monoclonal antibody specific for human tumor necrosis factor (TNF) indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, psoriasis, juvenile idiopathic arthritis, ulcerative colitis, hidradenitis suppurativa, and certain types of uveitis.
Labeling Revision Approved: March 27, 2017
Juvederm (dermal filler)
Date of Approval: June 2, 2006
Juvederm is a hyaluronic acid dermal filler indicated for the correction of facial wrinkles and folds.
New Formulation Approved: March 20, 2017
See approval history for Juvederm
Keytruda (pembrolizumab) for Injection
Date of Approval: September 4, 2014
Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody indicated for the treatment of metastatic melanoma, metastatic non-small cell lung cancer, recurrent or metastatic head and neck squamous cell carcinoma, and classical Hodgkin lymphoma.
New Indication Approved: March 14, 2017
See approval history for Keytruda
Revlimid (lenalidomide) Capsules
Date of Approval: December 27, 2005
Revlimid (lenalidomide) is an immunomodulatory drug indicated for the treatment of patients with multiple myeloma, transfusion-dependent anemia due myelodysplastic syndromes (MDS), and mantle cell lymphoma.
New Indication Approved: February 22, 2017
See approval history for Revlimid
Spiriva Respimat (tiotropium bromide) Inhalation Spray
Date of Approval: September 24, 2014
Spiriva Respimat (tiotropium bromide) is a long-acting muscarinic antagonist (LAMA) indicated for the long-term, maintenance treatment of chronic obstructive pulmonary disease (COPD) and asthma.
Patient Population Altered: February 15, 2017
See approval history for Spiriva Respimat
Opdivo (nivolumab) Injection
Date of 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 renal cell carcinoma, classical Hodgkin lymphoma, advanced squamous cell carcinoma of the head and neck, and urothelial carcinoma.
New Indication Approved: February 2, 2017
See approval history for Opdivo
Xyzal (levocetirizine dihydrochloride)
Date of Approval: May 25, 2007
Xyzal (levocetirizine) is an antihistamine for the relief of symptoms associated with allergic rhinitis and urticaria.
New Dosage Form Approved: January 31, 2017
See approval history for Xyzal
Latuda (lurasidone) Tablets
Date of Approval: October 28, 2010
Latuda (lurasidone) is an atypical antipsychotic agent for the treatment of schizophrenia and bipolar depression.
Patient Population Altered: January 27, 2017
See approval history for Latuda
Symbicort (budesonide and formoterol) Inhaler
Date of Approval: July 21, 2006
Symbicort (budesonide and formoterol) is a combination of a corticosteroid and a long-acting bronchodilator indicated for the long-term maintenance treatment of asthma and the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
Patient Population Altered: January 27, 2017
See approval history for Symbicort
Linzess (linaclotide) Capsules
Date of Approval: August 30, 2012
Linzess (linaclotide) is a guanylate cyclase-C agonist indicated in adults for treatment of irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).
New Dosage Form Approved: January 25, 2017
See approval history for Linzess
Narcan (naloxone) Nasal Spray
Date of Approval: November 18, 2015
Narcan Nasal Spray (naloxone) is an intranasal opioid antagonist formulation indicated for the emergency treatment of known or suspected opioid overdose.
New Dosage Form Approved: January 24, 2017
See approval history for Narcan
Imbruvica (ibrutinib) Capsules
Date of 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, and marginal zone lymphoma.
New Indication Approved: January 18, 2017
See approval history for Imbruvica
Lucentis (ranibizumab) Injection
Date of Approval: June 30, 2006
Lucentis (ranibizumab) is a humanized anti-VEGF antibody fragment indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization.
New Indication Approved: January 5, 2017
See approval history for Lucentis
Adynovate (antihemophilic factor (recombinant) pegylated)
Date of Approval: November 13, 2015
Adynovate (antihemophilic factor (recombinant) pegylated) is a human antihemophilic factor indicated for the control and prevention of bleeding episodes in patients with hemophilia A.
Patient Population Altered: December 22, 2016
See approval history for Adynovate
Tresiba (insulin degludec) Injection
Date of Approval: September 25, 2015
Tresiba (insulin degludec) is a long-acting basal insulin analogue indicated to improve glycemic control in patients one year of age and older with diabetes mellitus.
Patient Population Altered: December 16, 2016
See approval history for Tresiba
Synjardy (empagliflozin and metformin) Tablets
Date of Approval: August 26, 2015
Synjardy (empagliflozin and metformin hydrochloride) is a sodium glucose co-transporter-2 (SGLT2) inhibitor and biguanide combination for the treatment of adults with type 2 diabetes.
New Formulation Approved: December 12, 2016
See approval history for Synjardy
Avastin (bevacizumab) Injection
Date of 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.
New Indication Approved: December 6, 2016
See approval history for Avastin
Jardiance (empagliflozin) Tablets
Date of Approval: August 1, 2014
Jardiance (empagliflozin) is a sodium glucose co-transporter-2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes, and to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease.
New Indication Approved: December 2, 2016
- FDA Approves Jardiance (empagliflozin) to Reduce Cardiovascular Death in Adults with Type 2 Diabetes
See approval history for Jardiance
Veltassa (patiromer) for Oral Suspension
Date of Approval: October 21, 2015
Veltassa (patiromer) is an oral potassium binder for the treatment of hyperkalemia.
Labeling Revision Approved: November 25, 2016
See approval history for Veltassa
Darzalex (daratumumab) Injection
Date of Approval: November 16, 2015
Darzalex (daratumumab) is a human anti-CD38 monoclonal antibody indicated for the treatment of patients with multiple myeloma.
New Indication Approved: November 21, 2016
See approval history for Darzalex
FluLaval Quadrivalent (influenza virus vaccine)
Date of Approval: August 16, 2013
FluLaval Quadrivalent (influenza virus vaccine) is a vaccine indicated for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.
Patient Population Altered: November 18, 2016
See approval history for FluLaval Quadrivalent
Opdivo (nivolumab) Injection
Date of 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 renal cell carcinoma, classical Hodgkin lymphoma, advanced squamous cell carcinoma of the head and neck, and urothelial carcinoma.
New Indication Approved: November 10, 2016
See approval history for Opdivo
Enbrel (etanercept) Injection
Date of Approval: November 2, 1998
Enbrel (etanercept) is a tumor necrosis factor (TNF) blocker for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, and plaque psoriasis.
Patient Population Altered: November 4, 2016
Selzentry (maraviroc) Tablets
Date of Approval: August 6, 2007
Selzentry (maraviroc) is a CCR5 co-receptor antagonist indicated in combination with other antiretroviral agents for the treatment of only CCR5-tropic HIV-1 infection in patients 2 years of age and older.
New Formulation Approved: November 4, 2016
See approval history for Selzentry
Keytruda (pembrolizumab) for Injection
Date of Approval: September 4, 2014
Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody indicated for the treatment of metastatic melanoma, metastatic non-small cell lung cancer, recurrent or metastatic head and neck squamous cell carcinoma, and classical Hodgkin lymphoma.
New Indication Approved: October 24, 2016
See approval history for Keytruda
Vermox (mebendazole) Chewable Tablets
Date of Approval: June 28, 1974
Vermox Chewable is an anthelmintic indicated for the treatment of patients one year of age and older with gastrointestinal infections caused by roundworm (Ascaris lumbricoides) and whipworm (Trichuris trichiura).
New Formulation Approved: October 19, 2016
Tecentriq (atezolizumab) Injection
Date of Approval: May 18, 2016
Tecentriq (atezolizumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of patients with advanced urothelial carcinoma and patients with metastatic non-small cell lung cancer (NSCLC).
New Indication Approved: October 18, 2016
See approval history for Tecentriq
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