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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.

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

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

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

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