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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.

Keytruda (pembrolizumab) for Injection

New Indication Approved: September 17, 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, 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, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, and endometrial carcinoma.

Erleada (apalutamide) Tablets

New Indication Approved: September 17, 2019
Date of Original Approval: February 14, 2018

Erleada (apalutamide) is an oral androgen receptor inhibitor for the treatment of metastatic castration-sensitive prostate cancer, and non-metastatic castration-resistant prostate cancer.

Nucala (mepolizumab) Injection

Patient Population Altered: September 12, 2019
Date of Original Approval: November 4, 2015

Nucala (mepolizumab) is an interleukin-5 antagonist monoclonal antibody (IgG1 kappa) indicated for the add-on maintenance treatment of patients with severe eosinophilic asthma, and for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome).

Ofev (nintedanib) Capsules

New Indication Approved: September 6, 2019
Date of Original Approval: October 15, 2014

Ofev (nintedanib) is a small molecule tyrosine kinase inhibitor (TKI) indicated for the treatment of idiopathic pulmonary fibrosis, and systemic sclerosis-associated interstitial lung disease (SSc-ILD).

Juvederm (dermal filler)

New Indication Approved: September 3, 2019
Date of Original Approval: June 2, 2006

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

Taltz (ixekizumab) Injection

New Indication Approved: August 23, 2019
Date of Original Approval: March 22, 2016

Taltz (ixekizumab) is a humanized interleukin-17A antagonist indicated for the treatment of plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis.

Myobloc (rimabotulinumtoxinB) Injection

New Indication Approved: August 20, 2019
Date of Original Approval: December 8, 2000

Myobloc (rimabotulinumtoxinB) is an acetylcholine release inhibitor indicated for the treatment of cervical dystonia and chronic sialorrhea.

Eylea (aflibercept) Injection

New Dosage Form Approved: August 13, 2019
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.

Sirturo (bedaquiline) Tablets

Patient Population Altered: August 9, 2019
Date of Original Approval: December 28, 2012

Sirturo (bedaquiline) is an oral diarylquinoline antimycobacterial drug indicated for the treatment of pulmonary multi-drug resistant tuberculosis.

Keytruda (pembrolizumab) for Injection

New Indication Approved: July 30, 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, 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, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, and endometrial carcinoma.

Otezla (apremilast) Tablets

New Indication Approved: July 19, 2019
Date of Original Approval: March 21, 2014

Otezla (apremilast) is a phosphodiesterase 4 (PDE4) inhibitor indicated for the treatment of psoriatic arthritis, plaque psoriasis, and oral ulcers associated with Behçet’s Disease.

Gadavist (gadobutrol) Injection

New Indication Approved: July 12, 2019
Date of Original Approval: March 14, 2011

Gadavist (gadobutrol) is a gadolinium-based contrast agent indicated for use in diagnostic magnetic resonance imaging (MRI).

Soliris (eculizumab) Injection

New Indication Approved: June 27, 2019
Date of Original Approval: March 16, 2007

Soliris is a complement inhibitor indicated for:

  • the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis
  • the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy
  • the treatment of adult patients with generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive
  • the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

Darzalex (daratumumab) Injection

New Indication Approved: June 27, 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.

Dupixent (dupilumab) Injection

New Indication Approved: June 26, 2019
Date of Original Approval: March 28, 2017

Dupixent (dupilumab) is an interleukin-4 receptor alpha antagonist indicated for the treatment of atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis.

Doptelet (avatrombopag) Tablets

New Indication Approved: June 26, 2019
Date of Original Approval: May 21, 2018

Doptelet (avatrombopag) is a second generation, orally administered thrombopoietin receptor agonist (TPO-RA) indicated for the treatment of:

  • Thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.
  • Thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.

Somatuline Depot (lanreotide acetate) Injection

New Dosage Form Approved: June 24, 2019
Date of Original Approval: August 30, 2007

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

Symdeko (ivacaftor/tezacaftor and ivacaftor) Tablets

Patient Population Altered: June 21, 2019
Date of Original Approval: February 12, 2018

Symdeko (ivacaftor/tezacaftor tablets and ivacaftor tablets) is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator and CFTR corrector combination for the treatment of cystic fibrosis in patients aged 6 years and older who are homozygous for the F508del mutation or who have at least one mutation in the CFTR) gene that is responsive to Symdeko.

Botox (onabotulinumtoxinA) Injection

Patient Population Altered: June 20, 2019
Date of Original Approval: December 9, 1991

Botox (onabotulinumtoxinA) is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for:

  • treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication
  • treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition [e.g., spinal cord injury (SCI), multiple sclerosis (MS)] in adults who have an inadequate response to or are intolerant of an anticholinergic medication
  • prophylaxis of headaches in adult patients with chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer)
  • treatment of upper and lower limb spasticity in adult patients
  • treatment of upper limb spasticity in pediatric patients 2 to 17 years of age
  • treatment of cervical dystonia in adult patients, to reduce the severity of abnormal head position and neck pain
  • treatment of severe axillary hyperhidrosis that is inadequately managed by topical agents in adult patients
  • treatment of blepharospasm associated with dystonia in patients 12 years of age and older
  • treatment of strabismus in patients 12 years of age and older.

Dextenza (dexamethasone) Ophthalmic Insert

New Indication Approved: June 20, 2019
Date of Original Approval: November 30, 2018

Dextenza (dexamethasone ophthalmic insert) is a corticosteroid intracanalicular insert for the treatment of post-surgical ocular inflammation and pain.

Victoza (liraglutide) Injection

Patient Population Altered: June 17, 2019
Date of Original Approval: January 25, 2010

Victoza (liraglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve glycemic control in patients 10 years and older with type 2 diabetes mellitus, and to reduce the risk of heart attack, stroke and cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.

Keytruda (pembrolizumab) for Injection

New Indication Approved: June 17, 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, 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, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, and endometrial carcinoma.

Keytruda (pembrolizumab) for Injection

New Indication Approved: June 10, 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, 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, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, and endometrial carcinoma.

Emflaza (deflazacort) Tablets and Oral Suspension

Patient Population Altered: June 7, 2019
Date of Original Approval: February 9, 2017

Emflaza (deflazacort) is a glucocorticoid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.

Nucala (mepolizumab) Injection

New Formulation Approved: June 6, 2019
Date of Original Approval: November 4, 2015

Nucala (mepolizumab) is an interleukin-5 antagonist monoclonal antibody (IgG1 kappa) indicated for the add-on maintenance treatment of patients with severe eosinophilic asthma, and for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome).

Emgality (galcanezumab-gnlm) Injection

New Indication Approved: June 4, 2019
Date of Original Approval: September 27, 2018

Emgality (galcanezumab-gnlm) is a calcitonin gene-related peptide (CGRP) antagonist indicated for the preventive treatment of migraine, and for the treatment of episodic cluster headache.

Zerbaxa (ceftolozane and tazobactam) Injection

New Indication Approved: June 3, 2019
Date of Original Approval: December 19, 2014

Zerbaxa (ceftolozane and tazobactam) is a cephalosporin and beta-lactamase inhibitor combination for the treatment of:

  • complicated intra-abdominal Infections (cIAI), used in combination with metronidazole
  • complicated urinary tract infections (cUTI), including pyelonephritis
  • hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).

Revlimid (lenalidomide) Capsules

New Indication Approved: May 28, 2019
Date of Original Approval: December 27, 2005

Revlimid (lenalidomide) is a thalidomide analogue indicated for the treatment of adult patients with:

  • Multiple myeloma (MM), in combination with dexamethasone.
  • MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT).
  • Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities.
  • Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
  • Previously treated follicular lymphoma (FL), in combination with a rituximab product.
  • Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product.

Jakafi (ruxolitinib) Tablets

New Indication Approved: May 24, 2019
Date of Original Approval: November 16, 2011

Jakafi (ruxolitinib) is a Janus kinase (JAK) inhibitor indicated for the treatment of:

  • intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis in adults.
  • polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea.
  • steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older.

Vraylar (cariprazine) Capsules

New Indication Approved: May 24, 2019
Date of Original Approval: September 17, 2015

Vraylar (cariprazine) is a dopamine D3/D2 receptor partial agonist atypical antipsychotic for the:

  • treatment of schizophrenia in adults
  • acute treatment of manic or mixed episodes associated with bipolar I disorder in adults
  • treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults.

Fragmin (dalteparin sodium) Injection

Patient Population Altered: May 16, 2019
Date of Original Approval: December 22, 1994

Fragmin (dalteparin sodium) is a low molecular weight heparin (LMWH) indicated for:

  • Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction
  • Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery or medical patients with severely restricted mobility during acute illness
  • Extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in adult patients with cancer. In these patients, the Fragmin therapy begins with the initial VTE treatment and continues for six months
  • Treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in pediatric patients 1 month of age and older

Gattex (teduglutide) for Injection

Patient Population Altered: May 16, 2019
Date of Original Approval: December 21, 2012

Gattex (teduglutide) is a recombinant analog of human glucagon-like peptide 2 for the treatment of short bowel syndrome in adults and pediatric patients one year of age and older.

Venclexta (venetoclax) Tablets

New Indication Approved: May 15, 2019
Date of Original Approval: April 11, 2016

Venclexta (venetoclax) is an oral B-cell lymphoma-2 (BCL-2) inhibitor indicated:

  • for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
  • in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

Bavencio (avelumab) Injection

New Indication Approved: May 14, 2019
Date of Original 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); patients with advanced or metastatic urothelial carcinoma; and in combination with axitinib for patients with advanced renal cell carcinoma.

Eylea (aflibercept) Injection

New Indication Approved: May 13, 2019
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.

Cyramza (ramucirumab) Injection

New Indication Approved: May 10, 2019
Date of Original Approval: April 21, 2014

Cyramza (ramucirumab) is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated:

  • as a single agent or in combination with paclitaxel, for treatment of advanced or metastatic gastric cancer or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.
  • in combination with docetaxel, for treatment of metastatic non-small cell lung cancer with disease progression on or after platinum-based chemotherapy.
  • in combination with FOLFIRI, for the treatment of metastatic colorectal cancer with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.
  • as a single agent, for the treatment of hepatocellular carcinoma in patients who have an alpha fetoprotein of ≥400 ng/mL and have been treated with sorafenib.

Xeomin (incobotulinumtoxinA) Injection

New Indication Approved: May 10, 2019
Date of Original Approval: July 30, 2010

Xeomin (incobotulinumtoxinA) is a botulinum toxin type A for the treatment of cervical dystonia, blepharospasm, glabellar lines, upper limb spasticity, and excessive drooling.

Bivigam (immune globulin intravenous) Infusion

Labeling Revision Approved: May 10, 2019
Date of Original Approval: December 21, 2012

Bivigam is an immune globulin intravenous (human) indicated for the treatment of primary humoral immunodeficiency.

Sorilux (calcipotriene) Foam

Patient Population Altered: May 6, 2019
Date of Original Approval: October 7, 2010

Sorilux (calcipotriene) is a vitamin D analog indicated for the topical treatment of plaque psoriasis in patients 12 years and older.

Kadcyla (ado-trastuzumab emtansine) Injection

New Indication Approved: May 3, 2019
Date of Original Approval: February 22, 2013

Kadcyla (ado-trastuzumab emtansine) is a HER2-targeted antibody and microtubule inhibitor conjugate indicated for the treatment of patients with HER2-positive, metastatic breast cancer.

Tibsovo (ivosidenib) Tablets

New Indication Approved: May 2, 2019
Date of Original Approval: July 20, 2018

Tibsovo (ivosidenib) is an isocitrate dehydrogenase-1 (IDH1) inhibitor for the treatment of patients with acute myeloid leukemia who have an IDH1 mutation.

Mavyret (glecaprevir and pibrentasvir) Tablets

Patient Population Altered: April 30, 2019
Date of Original Approval: August 3, 2017

Mavyret (glecaprevir/pibrentasvir) is a fixed-dose combination of glecaprevir, an NS3/4A protease inhibitor, and pibrentasvir, an NS5A inhibitor, indicated for the treatment of all major genotypes (GT1-6) of chronic hepatitis C.

Kalydeco (ivacaftor) Tablets and Oral Granules

Patient Population Altered: April 29, 2019
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 6 months and older who have one mutation in the CFTR gene that is responsive to ivacaftor.

Benlysta (belimumab) Injection

Patient Population Altered: April 26, 2019
Date of Original Approval: March 10, 2011

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

Praluent (alirocumab) Injection

New Indication Approved: April 26, 2019
Date of Original Approval: July 24, 2015

Praluent (alirocumab) is a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor monoclonal antibody indicated:

  • as an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for the treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce low-density lipoprotein cholesterol LDL-C.
  • to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.

Keytruda (pembrolizumab) for Injection

New Indication Approved: April 19, 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, 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, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, and endometrial carcinoma.

Keytruda (pembrolizumab) for Injection

New Indication Approved: April 11, 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, 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, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, and endometrial carcinoma.

Ibrance (palbociclib) Capsules

New Indication Approved: April 4, 2019
Date of Original 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.

Zelnorm (tegaserod) Tablets

New Indication Approved: March 29, 2019
Date of Original Approval: July 24, 2002

Zelnorm (tegaserod) is a serotonin-4 (5-HT4) receptor agonist indicated for the treatment of adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C)

Cimzia (certolizumab pegol) Injection

New Indication Approved: March 28, 2019
Date of Original Approval: April 22, 2008

Cimzia (certolizumab) is a PEGylated anti-TNF (tumor necrosis factor) biologic therapy for the treatment of Crohn’s disease, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, and non-radiographic axial spondyloarthritis.

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