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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.

Somatuline Depot (lanreotide acetate) Injection

Somatuline Depot (lanreotide) is a long acting somatostatin analogue indicated for the treatment of acromegaly, gastroenteropancreatic neuroendocrine tumors, and carcinoid syndrome.

New Indication Approved: September 15, 2017

Date of Original Approval: August 30, 2007 (Somatuline Depot approval history)

Briviact (brivaracetam) Tablets, Solution and Injection

Briviact (brivaracetam) is a selective, high-affinity synaptic vesicle protein 2A ligand and analog of levetiracetam indicated for the treatment of partial-onset seizures in patients with epilepsy.

New Indication Approved: September 14, 2017

Date of Original Approval: February 19, 2016 (Briviact approval history)

Privigen (immune globulin intravenous (human)) Liquid

Privigen is an immune globulin intravenous (human), 10% liquid indicated for the treatment of primary humoral immunodeficiency (PI), chronic immune thrombocytopenic purpura (ITP), and chronic inflammatory demyelinating polyneuropathy (CIDP).

New Indication Approved: September 14, 2017

Date of Original Approval: July 26, 2007 (Privigen approval history)

Aptiom (eslicarbazepine acetate) Tablets

Aptiom (eslicarbazepine acetate) is a voltage-gated sodium channel blocker for the treatment of partial-onset seizures in patients with epilepsy.

Patient Population Altered: September 13, 2017

Date of Original Approval: November 8, 2013 (Aptiom approval history)

Tracleer (bosentan) Film-Coated Tablets and Tablets for Oral Suspension

Tracleer (bosentan) is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension.

New Dosage Form Approved: September 5, 2017

Date of Original Approval: November 20, 2001

Austedo (deutetrabenazine) Tablets

Austedo (deutetrabenazine) is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of chorea associated with Huntington’s disease and the treatment of tardive dyskinesia.

New Indication Approved: August 30, 2017

Date of Original Approval: April 3, 2017 (Austedo approval history)

Actemra (tocilizumab) Injection

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.

New Indication Approved: August 30, 2017

Date of Original Approval: January 8, 2010 (Actemra approval history)

Victoza (liraglutide) Injection

Victoza (liraglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve glycemic control in adults with type 2 diabetes mellitus, and to reduce the risk of heart attack, stroke and CV death in adults with type 2 diabetes and established CV disease.

New Indication Approved: August 25, 2017

Date of Original Approval: January 25, 2010 (Victoza approval history)

Faslodex (fulvestrant) Injection

Faslodex (fulvestrant) is an estrogen receptor antagonist indicated for the treatment of hormone receptor positive metastatic breast cancer.

New Indication Approved: August 25, 2017

Date of Original Approval: April 25, 2002

Dotarem (gadoterate meglumine) Injection

Dotarem (gadoterate meglumine) is a gadolinium-based contrast agent indicated for use in magnetic resonance imaging (MRI).

Patient Population Altered: August 25, 2017

Date of Original Approval: March 20, 2013 (Dotarem approval history)

Lynparza (olaparib) Capsules and Tablets

Lynparza (olaparib) is a first-in-class oral poly ADP ribose polymerase (PARP) inhibitor for the treatment of advanced ovarian cancer.

New Dosage Form Approved: August 17, 2017

Date of Original Approval: December 19, 2014 (Lynparza approval history)

Liletta (levonorgestrel) Intrauterine Device

Liletta (levonorgestrel) is a hormonal intrauterine device (IUD) for use by women to prevent pregnancy for up to four years.

New Indication Approved: August 3, 2017

Date of Original Approval: February 26, 2015 (Liletta approval history)

Imbruvica (ibrutinib) Capsules

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.

New Indication Approved: August 1, 2017

Date of Original Approval: November 13, 2013 (Imbruvica approval history)

Epclusa (sofosbuvir and velpatasvir) Tablets

Epclusa (sofosbuvir and velpatasvir) is a nucleotide analog polymerase inhibitor and pan-genotypic NS5A inhibitor fixed-dose combination for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection.

Patient Population Altered: August 1, 2017

Date of Original Approval: June 28, 2016 (Epclusa approval history)

Opdivo (nivolumab) Injection

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, urothelial carcinoma, and MSI-H or dMMR metastatic colorectal cancer.

New Indication Approved: July 31, 2017

Date of Original Approval: December 22, 2014 (Opdivo approval history)

Abilify Maintena (aripiprazole) for Extended-Release Injectable Suspension

Abilify Maintena (aripiprazole) is an atypical antipsychotic indicated for the treatment of schizophrenia, and maintenance monotherapy treatment of bipolar I disorder.

New Indication Approved: July 27, 2017

Date of Original Approval: February 28, 2013 (Abilify Maintena approval history)

Fycompa (perampanel) Tablets and Oral Suspension

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.

New Indication Approved: July 26, 2017

Date of Original Approval: October 22, 2012 (Fycompa approval history)

Yervoy (ipilimumab) Injection

Yervoy (ipilimumab) is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for the treatment of unresectable or metastatic melanoma.

Patient Population Altered: July 21, 2017

Date of Original Approval: March 25, 2011 (Yervoy approval history)

Benlysta (belimumab) Injection

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

New Formulation Approved: July 20, 2017

Date of Original Approval: March 10, 2011 (Benlysta approval history)

Blincyto (blinatumomab) Injection

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

Date of Original Approval: December 3, 2014 (Blincyto approval history)

Orencia (abatacept) Injection

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

Date of Original Approval: December 23, 2005 (Orencia approval history)

Vectibix (panitumumab) Injection

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

Date of Original Approval: September 27, 2006 (Vectibix approval history)

Darzalex (daratumumab) Injection

Darzalex (daratumumab) is a human anti-CD38 monoclonal antibody indicated for the treatment of patients with multiple myeloma.

New Indication Approved: June 16, 2017

Date of Original Approval: November 16, 2015 (Darzalex approval history)

Dysport (abobotulinumtoxinA) Injection

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

Date of Original Approval: April 29, 2009 (Dysport approval history)

Aristada (aripiprazole lauroxil) Injection

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

Date of Original Approval: October 5, 2015 (Aristada approval history)

Isentress (raltegravir) Tablets

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

Date of Original Approval: October 12, 2007 (Isentress approval history)

Zykadia (ceritinib) Capsules

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

Date of Original Approval: April 29, 2014 (Zykadia approval history)

Keytruda (pembrolizumab) for Injection

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

Date of Original Approval: September 4, 2014 (Keytruda approval history)

Actemra (tocilizumab) Injection

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.

New Indication Approved: May 22, 2017

Date of Original Approval: January 8, 2010 (Actemra approval history)

Keytruda (pembrolizumab) for Injection

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

Date of Original Approval: September 4, 2014 (Keytruda approval history)

Kalydeco (ivacaftor) Tablets

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

Date of Original Approval: January 31, 2012 (Kalydeco approval history)

Keytruda (pembrolizumab) for Injection

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

Date of Original Approval: September 4, 2014 (Keytruda approval history)

Bavencio (avelumab) Injection

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

Date of Original Approval: March 23, 2017 (Bavencio approval history)

Stivarga (regorafenib) Tablets

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

Date of Original Approval: September 27, 2012 (Stivarga approval history)

Praluent (alirocumab) Injection

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

Date of Original Approval: July 24, 2015 (Praluent approval history)

Tecentriq (atezolizumab) Injection

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

Date of Original Approval: May 18, 2016 (Tecentriq approval history)

Lucentis (ranibizumab) Injection

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

Date of Original Approval: June 30, 2006 (Lucentis approval history)

Harvoni (ledipasvir and sofosbuvir) Tablets

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

Date of Original Approval: October 10, 2014 (Harvoni approval history)

Sovaldi (sofosbuvir) Tablets

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

Date of Original Approval: December 6, 2013 (Sovaldi approval history)

Ibrance (palbociclib) Capsules

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

Date of Original Approval: February 3, 2015 (Ibrance approval history)

Tagrisso (osimertinib) Tablets

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

Date of Original Approval: November 13, 2015 (Tagrisso approval history)

Qudexy XR (topiramate) Extended-Release Capsules

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

Date of Original Approval: March 11, 2014 (Qudexy XR approval history)

Humira (adalimumab) Injection

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

Date of Original Approval: December 31, 2002

Juvederm (dermal filler)

Juvederm is a hyaluronic acid dermal filler indicated for the correction of facial wrinkles and folds.

New Formulation Approved: March 20, 2017

Date of Original Approval: June 2, 2006 (Juvederm approval history)

Keytruda (pembrolizumab) for Injection

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

Date of Original Approval: September 4, 2014 (Keytruda approval history)

Revlimid (lenalidomide) Capsules

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

Date of Original Approval: December 27, 2005 (Revlimid approval history)

Spiriva Respimat (tiotropium bromide) Inhalation Spray

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

Date of Original Approval: September 24, 2014 (Spiriva Respimat approval history)

Opdivo (nivolumab) Injection

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, urothelial carcinoma, and MSI-H or dMMR metastatic colorectal cancer.

New Indication Approved: February 2, 2017

Date of Original Approval: December 22, 2014 (Opdivo approval history)

Xyzal (levocetirizine dihydrochloride)

Xyzal (levocetirizine) is an antihistamine for the relief of symptoms associated with allergic rhinitis and urticaria.

New Dosage Form Approved: January 31, 2017

Date of Original Approval: May 25, 2007 (Xyzal approval history)

Latuda (lurasidone) Tablets

Latuda (lurasidone) is an atypical antipsychotic agent for the treatment of schizophrenia and bipolar depression.

Patient Population Altered: January 27, 2017

Date of Original Approval: October 28, 2010 (Latuda approval history)

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