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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.

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.

New Indication Approved: April 18, 2018

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

Afinitor (everolimus) Tablets

Afinitor (everolimus) is an oral once-daily inhibitor of mTOR indicated for the treatment of patients with advanced HR+, HER2- breast cancer; progressive neuroendocrine tumors of pancreatic origin (PNET); progressive neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin; advanced renal cell carcinoma; and subependymal giant cell astrocytoma (SEGA) and renal angiomyolipomas associated with tuberous sclerosis.

New Indication Approved: April 10, 2018

Date of Original Approval: March 30, 2009 (Afinitor approval history)

Rubraca (rucaparib) Tablets

Rubraca (rucaparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of patients with deleterious BRCA mutation (germline and/or somatic)-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies; and for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

New Indication Approved: April 6, 2018

Date of Original Approval: December 19, 2016 (Rubraca approval history)

Exparel (bupivacaine liposome) Injectable Suspension

Exparel (bupivacaine liposome injectable suspension) is a long-acting non-opioid local analgesic for postsurgical local analgesia, and for use as a nerve block (interscalene brachial plexus block) to provide pain relief following shoulder surgeries.

New Indication Approved: April 6, 2018

Date of Original Approval: October 28, 2011 (Exparel 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.

Labeling Revision Approved: April 2, 2018

Date of Original Approval: January 27, 2012 (Bydureon 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), and minimal residual disease (MRD)-positive B-cell precursor ALL.

New Indication Approved: March 29, 2018

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

Toujeo SoloStar (insulin glargine [rDNA origin]) Injection

Toujeo SoloStar (insulin glargine [rDNA origin] is a once-daily long-acting basal insulin used to improve glycemic control in adults with type 1 and type 2 diabetes.

New Formulation Approved: March 26, 2018

Date of Original Approval: February 25, 2015 (Toujeo SoloStar 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).

Patient Population Altered: March 22, 2018

Date of Original Approval: October 29, 2007 (Tasigna 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: March 20, 2018

Date of Original Approval: August 19, 2011 (Adcetris 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 Dosage Form Approved: March 20, 2018

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

Hizentra (immune globulin subcutaneous (human)) Liquid

Hizentra (immune globulin subcutaneous (human)) is an immune globulin indicated for the treatment of primary immunodeficiency, and for the maintenance treatment of chronic inflammatory demyelinating polyneuropathy.

New Indication Approved: March 15, 2018

Date of Original Approval: March 4, 2010 (Hizentra 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 Dosage Regimen: March 5, 2018

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

Latuda (lurasidone) Tablets

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

Patient Population Altered: March 5, 2018

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

Otiprio (ciprofloxacin) Otic Suspension

Otiprio (ciprofloxacin otic suspension) is a single-dose, physician-administered, sustained-exposure otic fluoroquinolone antibacterial for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement surgery, and for the treatment of acute otitis externa due to Pseudomonas aeruginosa and Staphylococcus aureus.

New Indication Approved: March 2, 2018

Date of Original Approval: December 10, 2015 (Otiprio approval history)

Verzenio (abemaciclib) Tablets

Verzenio (abemaciclib) is a selective ATP-competitive inhibitor of cyclin dependent kinases (CDK) 4 and 6 indicated for the treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer.

New Indication Approved: February 26, 2018

Date of Original Approval: September 28, 2017 (Verzenio approval history)

Luzu (luliconazole) Topical Cream

Luzu (luliconazole) Cream is an azole antifungal indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis.

Patient Population Altered: February 20, 2018

Date of Original Approval: November 14, 2013 (Luzu approval history)

Imfinzi (durvalumab) Injection

Imfinzi (durvalumab) is an anti-PD-L1 (programmed death ligand-1) human monoclonal antibody for the treatment of patients with metastatic urothelial carcinoma and for the treatment of patients with unresectable non-small cell lung cancer that has not progressed after chemoradiation.

New Indication Approved: February 16, 2018

Date of Original Approval: May 1, 2017 (Imfinzi approval history)

Makena (hydroxyprogesterone caproate) Injection

Makena (hydroxyprogesterone caproate) is a long acting form of natural progesterone for the prevention of preterm birth in pregnant women.

New Dosage Form Approved: February 14, 2018

Date of Original Approval: February 3, 2011 (Makena approval history)

Zytiga (abiraterone) Tablets

Zytiga (abiraterone acetate) is a CYP17 inhibitor indicated for the treatment of patients with metastatic castration-resistant prostate cancer and metastatic high-risk castration-sensitive prostate cancer.

New Indication Approved: February 7, 2018

Date of Original Approval: April 28, 2011 (Zytiga approval history)

Feraheme (ferumoxytol) Intravenous Injection

Feraheme (ferumoxytol) is an iron replacement therapy for the treatment of iron deficiency anemia in adult patients.

New Indication Approved: February 2, 2018

Date of Original Approval: June 30, 2009 (Feraheme approval history)

Avycaz (avibactam and ceftazidime) Injection

Avycaz (avibactam and ceftazidime) is a next generation, non-β lactam β-lactamase inhibitor and third-generation, antipseudomonal cephalosporin antibiotic combination for the treatment of complicated intra-abdominal infections, complicated urinary tract infections, hospital-acquired bacterial pneumonia, and ventilator-associated bacterial pneumonia.

New Indication Approved: February 1, 2018

Date of Original Approval: February 25, 2015 (Avycaz approval history)

Trulance (plecanatide) Tablets

Trulance (plecanatide) is a guanylate cyclase-C agonist for the treatment of chronic idiopathic constipation, and irritable bowel syndrome with constipation (IBS-C).

New Indication Approved: January 25, 2018

Date of Original Approval: January 19, 2017 (Trulance 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: 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)

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