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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.

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 combination treatment of patients with multiple myeloma who have received at one three prior therapy.

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

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 Dosage Form Approved: October 13, 2016

See approval history for Lucentis

Flublok (influenza vaccine) Injection

Date of Approval: January 16, 2013

FluBlok (influenza vaccine, recombinant hemagglutinin) is an influenza vaccine indicated for active immunization against seasonal influenza in adults 18 years of age and older .

New Formulation Approved: October 7, 2016

See approval history for Flublok

Orkambi (ivacaftor and lumacaftor) Tablets

Date of 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 6 years and older with two copies of the F508del mutation in their CFTR gene.

Patient Population Altered: September 28, 2016

See approval history for Orkambi

Ilaris (canakinumab) Injection

Date of Approval: June 17, 2009

Ilaris (canakinumab) is a human anti-interleukin-1β monoclonal antibody for the treatment of Periodic Fever Syndromes (Cryopyrin-Associated Periodic Syndromes, Tumor Necrosis Factor Receptor Associated Periodic Syndrome, Hyperimmunoglobulin D Syndrome/Mevalonate Kinase Deficiency, Familial Mediterranean Fever) and active Systemic Juvenile Idiopathic Arthritis.

New Indication Approved: September 23, 2016

See approval history for Ilaris

Stelara (ustekinumab) Injection

Date of Approval: September 25, 2009

Stelara (ustekinumab) is a human monoclonal antibody for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active Crohn's disease.

New Indication Approved: September 23, 2016

See approval history for Stelara

Rexulti (brexpiprazole) Tablets

Date of Approval: July 10, 2015

Rexulti (brexpiprazole) is a serotonin-dopamine activity modulator (SDAM) for the treatment of schizophrenia and the adjunctive treatment of major depressive disorder.

Labeling Revision Approved: September 23, 2016

See approval history for Rexulti

Invokamet (canagliflozin and metformin) Tablets

Date of Approval: August 8, 2014

Invokamet (canagliflozin/metformin) is a selective sodium glucose co-transporter 2 (SGLT2) inhibitor and biguanide combination for the treatment of type 2 diabetes.

New Dosage Form Approved: September 20, 2016

See approval history for Invokamet

Arzerra (ofatumumab) Injection

Date of Approval: October 26, 2009

Arzerra (ofatumumab) is a CD20-directed cytolytic monoclonal antibody indicated for the treatment of patients with chronic lymphocytic leukemia.

New Indication Approved: August 30, 2016

See approval history for Arzerra

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).

Patient Population Altered: August 30, 2016

See approval history for Blincyto

Afluria (influenza virus vaccine) Injection

Date of Approval: September 28, 2007

Afluria (influenza virus vaccine) is an inactivated influenza virus vaccine, indicated for active immunization of persons ages 18 years and older against influenza disease.

New Formulation Approved: August 29, 2016

See approval history for Afluria

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: August 5, 2016

See approval history for Keytruda

Dysport (abobotulinumtoxinA) Injection

Date of Approval: April 29, 2009

Dysport (abobotulinumtoxinA) is an acetylcholine release inhibitor and neuromuscular blocking agent for the treatment of cervical dystonia, for the temporary improvement in the appearance of moderate to severe glabellar lines, upper limb spasticity in adults, and lower limb spasticity in pediatric patients.

New Indication Approved: July 27, 2016

See approval history for Dysport

Relistor (methylnaltrexone bromide) Tablets and Subcutaneous Injection

Date of Approval: April 25, 2008

Relistor (methylnaltrexone) is a peripherally acting mu-opioid receptor antagonist indicated to treat opioid-induced constipation.

New Dosage Form Approved: July 19, 2016

See approval history for Relistor

Belviq (lorcaserin) Tablets

Date of Approval: June 27, 2012

Belviq (lorcaserin) is a serotonin 2C receptor agonist indicated for chronic weight management in adults who are obese, or overweight and who have at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol.

New Formulation Approved: July 15, 2016

See approval history for Belviq

Prevnar 13 (pneumococcal 13-valent conjugate vaccine)

Date of Approval: February 24, 2010

Prevnar 13 (pneumococcal 13-valent conjugate vaccine) is a vaccine indicated for active immunization against invasive pneumococcal disease.

Patient Population Altered: July 11, 2016

See approval history for Prevnar 13

Differin (adapalene)

Date of Approval: May 31, 1996

Differin (adapalene) is a retinoid product indicated for the topical treatment of acne vulgaris in patients 12 years and older.

Labeling Revision Approved: July 8, 2016

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.

Patient Population Altered: July 8, 2016

See approval history for Synjardy

Repatha (evolocumab) Injection

Date of Approval: August 27, 2015

Repatha (evolocumab) is a monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) indicated for the treatment of patients with heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH), or patients with atherosclerotic heart disease who require additional lowering of LDL-cholesterol.

New Formulation Approved: July 8, 2016

See approval history for Repatha

Xolair (omalizumab) Subcutaneous Injection

Date of 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.

Patient Population Altered: July 7, 2016

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.

New Indication Approved: June 30, 2016

Flublok (influenza vaccine) Injection

Date of Approval: January 16, 2013

FluBlok (influenza vaccine, recombinant hemagglutinin) is an influenza vaccine indicated for active immunization against seasonal influenza in adults 18 years of age and older .

New Formulation Approved: June 23, 2016

See approval history for Flublok

Prezista (darunavir) Tablets

Date of Approval: June 23, 2006

Prezista (darunavir) is a protease inhibitor used with ritonavir in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV) infection.

Patient Population Altered: June 17, 2016

See approval history for Prezista

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: June 1, 2016

See approval history for Juvederm

Jentadueto (linagliptin and metformin hydrochloride) Tablets

Date of Approval: January 30, 2012

Jentadueto (linagliptin and metformin) is a dipeptidyl peptidase-4 (DPP-4) inhibitor and biguanide combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

New Formulation Approved: May 31, 2016

See approval history for Jentadueto

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