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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.

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

New Indication Approved: January 20, 2018

Date of Original Approval: December 22, 2014 (Opdivo 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 BRCA-mutated, advanced ovarian cancer; for the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer; and for the treatment of germline BRCA-mutated metastatic breast cancer.

New Indication Approved: January 12, 2018

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

Gilotrif (afatinib) Tablets

Gilotrif (afatinib) is a kinase inhibitor indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC).

New Indication Approved: January 12, 2018

Date of Original Approval: July 12, 2013 (Gilotrif approval history)

Fluarix (influenza virus vaccine, inactivated)

Fluarix (influenza virus vaccine, inactivated) is an influenza virus vaccine indicated for the prevention of influenza.

Patient Population Altered: January 11, 2018

Date of Original Approval: August 31, 2005 (Fluarix approval history)

Xgeva (denosumab) Injection

Xgeva (denosumab) is a RANK ligand (RANKL) inhibitor indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. Xgeva is also indicated for treatment giant cell tumor of bone and for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

New Indication Approved: January 4, 2018

Date of Original Approval: November 18, 2010 (Xgeva approval history)

Tasigna (nilotinib) Capsules

Tasigna (nilotinib) is a kinase inhibitor indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (CML).

New Dosage Regimen: December 22, 2017

Date of Original Approval: October 29, 2007 (Tasigna approval history)

Perjeta (pertuzumab) Injection

Perjeta (pertuzumab) is a humanized monoclonal antibody indicated for the treatment of HER2-positive breast cancer.

New Indication Approved: December 20, 2017

Date of Original Approval: June 8, 2012 (Perjeta approval history)

Bosulif (bosutinib) Tablets

Bosulif (bosutinib) is a kinase inhibitor indicated for the treatment of adult patients with chronic, accelerated, or blast phase Ph+ chronic myelogenous leukemia (CML).

New Indication Approved: December 19, 2017

Date of Original Approval: September 4, 2012 (Bosulif approval history)

Cabometyx (cabozantinib) Tablets

Cabometyx (cabozantinib) is a tyrosine kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC).

New Indication Approved: December 19, 2017

Date of Original Approval: April 25, 2016 (Cabometyx approval history)

Xeljanz (tofacitinib) Tablets

Xeljanz (tofacitinib) is an oral Janus kinase (JAK) inhibitor for the treatment of adult patients with moderately to severely active rheumatoid arthritis and adult patients with active psoriatic arthritis.

New Indication Approved: December 14, 2017

Date of Original Approval: November 6, 2012 (Xeljanz approval history)

Nucala (mepolizumab) Injection

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).

New Indication Approved: December 12, 2017

Date of Original Approval: November 4, 2015 (Nucala approval history)

Omidria (ketorolac and phenylephrine) Injection

Omidria (ketorolac and phenylephrine) is an anti-inflammatory and mydriatic combination added to irrigation solution during cataract surgery and intraocular lens replacement procedures.

Patient Population Altered: December 12, 2017

Date of Original Approval: May 30, 2014 (Omidria approval history)

Avastin (bevacizumab) Injection

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.

Labeling Revision Approved: December 5, 2017

Date of Original Approval: February 26, 2004 (Avastin approval history)

Repatha (evolocumab) Injection

Repatha (evolocumab) is a monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) indicated for the treatment of patients with heterozygous familial hypercholesterolemia; homozygous familial hypercholesterolemia; and to reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease.

New Indication Approved: December 1, 2017

Date of Original Approval: August 27, 2015 (Repatha approval history)

Taltz (ixekizumab) Injection

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

New Indication Approved: December 1, 2017

Date of Original Approval: March 22, 2016 (Taltz 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.

Patient Population Altered: November 22, 2017

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

Auvi-Q (epinephrine) Injection

Auvi-Q (epinephrine injection) is a voice-guided epinephrine auto-injector for the emergency treatment of life-threatening allergic reactions in people who are at risk for or have a history of anaphylaxis.

Patient Population Altered: November 17, 2017

Date of Original Approval: August 10, 2012 (Auvi-Q approval history)

Sutent (sunitinib malate) Capsules

Sutent (sunitinib malate) is an oral multi-kinase inhibitor indicated for the treatment of gastrointestinal stromal tumors, advanced renal cell carcinoma (RCC), adjuvant treatment of patients at high risk of recurrent RCC following nephrectomy, and the treatment of pancreatic neuroendocrine tumors.

New Indication Approved: November 16, 2017

Date of Original Approval: January 26, 2006 (Sutent approval history)

Gazyva (obinutuzumab) Injection

Gazyva (obinutuzumab) is a CD20-directed cytolytic antibody indicated for the combination treatment of patients with chronic lymphocytic leukemia and follicular lymphoma.

New Indication Approved: November 16, 2017

Date of Original Approval: November 1, 2013 (Gazyva approval history)

Tekturna (aliskiren) Tablets and Oral Pellets

Tekturna (aliskiren) is a direct renin inhibitor indicated as a once-daily oral therapy for the treatment of high blood pressure.

New Dosage Form Approved: November 14, 2017

Date of Original Approval: March 5, 2007 (Tekturna 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: November 14, 2017

Date of Original Approval: April 25, 2002

Vraylar (cariprazine) Capsules

Vraylar (cariprazine) is a dopamine D3/D2 receptor partial agonist atypical antipsychotic for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia.

New Indication Approved: November 9, 2017

Date of Original Approval: September 17, 2015 (Vraylar approval history)

Sprycel (dasatinib) Tablets

Sprycel (dasatinib) is a kinase inhibitor indicated for the treatment of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia.

Patient Population Altered: November 9, 2017

Date of Original Approval: June 28, 2006 (Sprycel approval history)

Adcetris (brentuximab vedotin) Injection

Adcetris (brentuximab vedotin) is a CD30-directed antibody-drug conjugate (ADC) indicated for the treatment of Hodgkin lymphoma, anaplastic large cell lymphoma, and CD30-expressing mycosis fungoides.

New Indication Approved: November 9, 2017

Date of Original Approval: August 19, 2011 (Adcetris approval history)

Auryxia (ferric citrate) Tablets

Auryxia (ferric citrate) is a phosphate binder indicated for the control of serum phosphorus levels in dialysis patients; and an iron replacement product for the treatment of iron deficiency anemia in adult patients with chronic kidney disease who are not on dialysis.

New Indication Approved: November 7, 2017

Date of Original Approval: September 5, 2014 (Auryxia approval history)

Zelboraf (vemurafenib) Tablets

Zelboraf (vemurafenib) is a kinase inhibitor indicated for the treatment of patients with metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test, and for the treatment of patients with Erdheim-Chester Disease with BRAF V600 mutation.

New Indication Approved: November 6, 2017

Date of Original Approval: August 17, 2011 (Zelboraf approval history)

Alecensa (alectinib) Capsules

Alecensa (alectinib) is an oral, anaplastic lymphoma kinase (ALK) inhibitor for the treatment of ALK-positive non-small cell lung cancer (NSCLC).

New Indication Approved: November 6, 2017

Date of Original Approval: December 11, 2015 (Alecensa approval history)

Xarelto (rivaroxaban) Tablets

Xarelto (rivaroxaban) is a factor Xa inhibitor indicated for the prophylaxis of deep vein thrombosis (DVT) in patients undergoing knee or hip replacement surgery, to reduce the risk of stroke in people who have abnormal heart rhythm (non-valvular atrial fibrillation) and to treat and reduce the risk of deep vein thrombosis (DVT) or pulmonary embolism (PE)

New Dosage Regimen: October 27, 2017

Date of Original Approval: July 1, 2011 (Xarelto approval history)

Varubi (rolapitant) Tablets and Injection

Varubi (rolapitant) is a substance P/neurokinin 1 (NK1) receptor antagonist indicated for use in the prevention of delayed nausea and vomiting associated with emetogenic chemotherapy.

New Formulation Approved: October 25, 2017

Date of Original Approval: September 1, 2015 (Varubi approval history)

Soliris (eculizumab) Injection

Soliris (eculizumab) is a monoclonal antibody indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, and for the treatment of patients with atypical hemolytic uremic syndrome.

New Indication Approved: October 23, 2017

Date of Original Approval: March 16, 2007 (Soliris approval history)

Bydureon (exenatide) Extended-Release Injectable Suspension

Bydureon (exenatide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve glycemic control in patients with type 2 diabetes.

New Formulation Approved: October 20, 2017

Date of Original Approval: January 27, 2012 (Bydureon approval history)

Simponi (golimumab) Injection

Simponi (golimumab) is a human anti-tumor necrosis factor (TNF)-alpha monoclonal antibody for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis.

New Indication Approved: October 20, 2017

Date of Original Approval: April 24, 2009 (Simponi approval history)

Stelara (ustekinumab) Injection

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.

Patient Population Altered: October 13, 2017

Date of Original Approval: September 25, 2009 (Stelara approval history)

Lyrica (pregabalin) Capsules

Lyrica (pregabalin) is a structural derivative of the inhibitory neurotransmitter gamma aminobutyric acid indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia and spinal cord injury; as an adjunctive therapy for partial onset seizures and for the treatment of fibromyalgia.

New Dosage Form Approved: October 12, 2017

Date of Original Approval: December 30, 2004 (Lyrica approval history)

Botox Cosmetic (onabotulinumtoxinA) for Injection

Botox Cosmetic (onabotulinumtoxinA) is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for the temporary improvement in the appearance of glabellar lines and lateral canthal lines (crow’s feet).

New Indication Approved: October 2, 2017

Date of Original Approval: April 12, 2002

Keytruda (pembrolizumab) for Injection

Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody indicated for the treatment of melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, urothelial carcinoma, microsatellite instability-high cancer, and gastric cancer.

New Indication Approved: September 22, 2017

Date of Original Approval: September 4, 2014 (Keytruda 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, MSI-H or dMMR metastatic colorectal cancer, and hepatocellular carcinoma.

New Indication Approved: September 22, 2017

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

Rapivab (peramivir) Injection

Rapivab (peramivir) is an influenza virus neuraminidase inhibitor indicated for the treatment of acute uncomplicated influenza.

Patient Population Altered: September 20, 2017

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

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

Afluria (influenza virus vaccine) Injection

Afluria (influenza virus vaccine) is an inactivated influenza virus vaccine, indicated for active immunization against influenza disease.

Patient Population Altered: August 31, 2017

Date of Original Approval: September 28, 2007 (Afluria approval history)

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 BRCA-mutated, advanced ovarian cancer; for the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer; and for the treatment of germline BRCA-mutated metastatic breast cancer.

New Dosage Form Approved: August 17, 2017

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

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