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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.

Ferriprox (deferiprone) Tablets and Oral Solution

New Indication Approved: May 1, 2021
Date of Original Approval: October 14, 2011

Ferriprox (deferiprone) is an iron chelator indicated for the treatment of transfusional iron overload in:
  • thalassemia syndromes
  • sickle cell disease or other anemias.
Ferriprox Tablets are indicated in adult and pediatric patients ≥8 years of age and Ferriprox Oral Solution is indicated in patients ≥3 years of age.

Farxiga (dapagliflozin) Tablets

New Indication Approved: April 30, 2021
Date of Original Approval: January 8, 2014

Farxiga (dapagliflozin) is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated for the treatment of type 2 diabetes mellitus, heart failure, and chronic kidney disease.

Opdivo (nivolumab) Injection

New Indication Approved: April 16, 2021
Date of Original Approval: December 22, 2014

Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of melanoma, non-small cell lung cancer, small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, MSI-H or dMMR metastatic colorectal cancer, hepatocellular carcinoma, and esophageal squamous cell carcinoma.

Ragwitek (ragweed pollen allergen extract)

Patient Population Altered: April 16, 2021
Date of Original Approval: April 17, 2014

Ragwitek (short ragweed pollen allergen extract) is a sublingual immunotherapy for the treatment of ragweed allergies.

Trodelvy (sacituzumab govitecan-hziy) Injection

New Indication Approved: April 13, 2021
Date of Original Approval: April 22, 2020

Trodelvy (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of metastatic triple-negative breast cancer (mTNBC) and metastatic urothelial cancer (mUC).

Xolair (omalizumab) Subcutaneous Injection

New Dosage Form Approved: April 9, 2021
Date of Original Approval: June 20, 2003

Xolair (omalizumab) is an anti-IgE monoclonal antibody indicated for:
  • moderate to severe persistent asthma in patients 6 years of age and older
  • chronic idiopathic urticaria in adults and adolescents 12 years of age and older
  • nasal polyps in adult patients 18 years of age and older.

Trodelvy (sacituzumab govitecan-hziy) Injection

Labeling Revision Approved: April 7, 2021
Date of Original Approval: April 22, 2020

Trodelvy (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of metastatic triple-negative breast cancer (mTNBC) and metastatic urothelial cancer (mUC).

Sarclisa (isatuximab-irfc) Injection

New Indication Approved: March 31, 2021
Date of Original Approval: March 2, 2020

Sarclisa (isatuximab-irfc) is a CD38-directed cytolytic antibody indicated:
  • in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor.
  • in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.

Vyxeos (cytarabine and daunorubicin) Injection

Patient Population Altered: March 30, 2021
Date of Original Approval: August 3, 2017

Vyxeos (cytarabine and daunorubicin liposome injection) is a liposomal combination of cytarabine, a nucleoside metabolic inhibitor, and daunorubicin, an anthracycline topoisomerase inhibitor, indicated for the treatment of newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older.

Myrbetriq (mirabegron) Extended Release Tablets and Granules

New Dosage Form Approved: March 25, 2021
Date of Original Approval: June 28, 2012

Myrbetriq (mirabegron) is a beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency, and neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more.
Myrbetriq Granules is indicated for the treatment of NDO in pediatric patients aged 3 years and older.

Keytruda (pembrolizumab) for Injection

New Indication Approved: March 22, 2021
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, endometrial carcinoma, tumor mutational burden-high (TMB-H) cancer, cutaneous squamous cell carcinoma, and triple-negative breast cancer.

Arcalyst (rilonacept) Injection

New Indication Approved: March 18, 2021
Date of Original Approval: February 27, 2008

Arcalyst (rilonacept) is an interleukin-1 inhibitor indicated for the:

  • treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS), and Muckle-Wells Syndrome (MWS) in adults and children 12 years and older
  • maintenance of remission of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) in adults and pediatric patients weighing 10 kg or more
  • treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and children 12 years and older.

Yescarta (axicabtagene ciloleucel) Suspension for Intravenous Infusion

New Indication Approved: March 5, 2021
Date of Original Approval: October 18, 2017

Yescarta (axicabtagene ciloleucel) is a CD19-directed genetically modified autologous T cell immunotherapy (CAR T-cell therapy) indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B cell lymphoma, and DLBCL arising from follicular lymphoma.

Lorbrena (lorlatinib) Tablets

New Indication Approved: March 3, 2021
Date of Original Approval: November 2, 2018

Lorbrena (lorlatinib) is an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) positive as detected by an FDA-approved test.

Humira (adalimumab) Injection

Patient Population Altered: February 24, 2021
Date of Original 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.

Libtayo (cemiplimab-rwlc) Injection

New Indication Approved: February 22, 2021
Date of Original Approval: September 28, 2018

Libtayo (cemiplimab-rwlc) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of cutaneous squamous cell carcinoma (CSCC), basal cell carcinoma (BCC), and non-small cell lung cancer (NSCLC).

Entresto (sacubitril and valsartan) Tablets

Labeling Revision Approved: February 16, 2021
Date of Original Approval: July 7, 2015

Entresto (sacubitril and valsartan) is a neprilysin inhibitor and angiotensin II receptor blocker combination indicated:

  • to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal.
  • for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Entresto reduces NT-proBNP and is expected to improve cardiovascular outcomes.

Libtayo (cemiplimab-rwlc) Injection

New Indication Approved: February 9, 2021
Date of Original Approval: September 28, 2018

Libtayo (cemiplimab-rwlc) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of cutaneous squamous cell carcinoma (CSCC), basal cell carcinoma (BCC), and non-small cell lung cancer (NSCLC).

Botox (onabotulinumtoxinA) Injection

New Indication Approved: February 9, 2021
Date of Original Approval: December 9, 1991

Botox (onabotulinumtoxinA) is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for the treatment of overactive bladder, urinary incontinence, prophylaxis of headaches in adult patients with chronic migraine, spasticity, cervical dystonia, axillary hyperhidrosis, blepharospasm, and strabismus.

Gocovri (amantadine hydrochloride) Extended-Release Capsules

New Indication Approved: February 1, 2021
Date of Original Approval: August 24, 2017

Gocovri (amantadine hydrochloride) is a chrono-synchronous amantadine therapy indicated:
  • for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
  • as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes.

Plegridy (peginterferon beta-1a) Injection

New Dosage Form Approved: January 29, 2021
Date of Original Approval: August 15, 2014

Plegridy (peginterferon beta-1a) is a pegylated interferon beta indicated for the treatment of patients with relapsing forms of multiple sclerosis.

Rapivab (peramivir) Injection

Patient Population Altered: January 28, 2021
Date of Original Approval: December 19, 2014

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

Opdivo (nivolumab) Injection

New Indication Approved: January 21, 2021
Date of Original Approval: December 22, 2014

Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of melanoma, non-small cell lung cancer, small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, MSI-H or dMMR metastatic colorectal cancer, hepatocellular carcinoma, and esophageal squamous cell carcinoma.

Enhertu (fam-trastuzumab deruxtecan-nxki) Injection

New Indication Approved: January 15, 2021
Date of Original Approval: December 20, 2019

Enhertu (fam-trastuzumab deruxtecan-nxki) is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting; and adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.

Darzalex Faspro (daratumumab and hyaluronidase-fihj) Injection

New Indication Approved: January 15, 2021
Date of Original Approval: May 1, 2020

Darzalex Faspro (daratumumab and hyaluronidase-fihj) is a combination of daratumumab (a CD38-directed cytolytic antibody) and hyaluronidase (an endoglycosidase) indicated for the treatment of multiple myeloma and light chain (AL) amyloidosis.

Xalkori (crizotinib) Capsules

New Indication Approved: January 14, 2021
Date of Original Approval: August 26, 2011

Xalkori (crizotinib) is an oral anaplastic lymphoma kinase (ALK) inhibitor indicated for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors are ALK-positive or ROS1-positive, and for the the treatment of pediatric patients and young adults 1 year of age and older with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive.

Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) Tablets

Labeling Revision Approved: December 21, 2020
Date of Original Approval: October 21, 2019

Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is a triple combination regimen for the treatment of cystic fibrosis (CF) in patients ages 12 years and older who have at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Tagrisso (osimertinib) Tablets

New Indication Approved: December 20, 2020
Date of Original Approval: November 13, 2015

Tagrisso (osimertinib) is a tyrosine kinase inhibitor (TKI) of epidermal growth factor receptor (EGFR) indicated:
    • as adjuvant therapy after tumor resection in adult patients with non small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
    • for the first-line treatment of adult patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
    • for the treatment of adult patients with metastatic EGFR T790M mutationpositive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy.

Xpovio (selinexor) Tablets

New Indication Approved: December 18, 2020
Date of Original Approval: July 3, 2019

Xpovio (selinexor) is a first in class Selective Inhibitor of Nuclear Export (SINE) XPO1 antagonist for the treatment of patients adult patients with multiple myeloma (RRMM) and relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Xeomin (incobotulinumtoxinA) Injection

Patient Population Altered: December 18, 2020
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.

Iclusig (ponatinib) Tablets

New Indication Approved: December 18, 2020
Date of Original Approval: December 14, 2012

Iclusig (ponatinib) is a kinase inhibitor indicated for the treatment of adult patients with:
  • Chronic phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors.
  • Accelerated phase (AP) or blast phase (BP) CML or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other kinase inhibitors are indicated.
  • T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ ALL.

Kineret (anakinra) Injection

New Indication Approved: December 18, 2020
Date of Original Approval: November 14, 2001

Kineret (anakinra) is an interleukin-1 receptor antagonist indicated for the treatment of rheumatoid arthritis, Cryopyrin-Associated Periodic Syndromes (CAPS), and Deficiency of Interleukin-1 Receptor Antagonist (DIRA).

Benlysta (belimumab) Injection

New Indication Approved: December 16, 2020
Date of Original Approval: March 10, 2011

Benlysta (belimumab) is B-lymphocyte stimulator (BLyS)-specific inhibitor indicated for the treatment of patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE), and adult patients with active lupus nephritis.

Ocrevus (ocrelizumab) Injection

New Dosage Regimen: December 14, 2020
Date of Original Approval: March 28, 2017

Ocrevus (ocrelizumab) is a humanized monoclonal antibody designed to selectively target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin and axonal nerve cell damage. Ocrevus is indicated as a treatment for both relapsing (RMS) and primary progressive (PPMS) forms of multiple sclerosis.

Saxenda (liraglutide) Injection

Patient Population Altered: December 4, 2020
Date of Original Approval: December 23, 2014

Saxenda (liraglutide) is a once-daily glucagon-like peptide-1 (GLP-1) analogue for the treatment of obesity.

Gavreto (pralsetinib) Capsules

New Indication Approved: December 1, 2020
Date of Original Approval: September 4, 2020

Gavreto (pralsetinib) is an oral selective RET kinase inhibitor for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion- positive non-small cell lung cancer (NSCLC), and adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC).

Xolair (omalizumab) Subcutaneous Injection

New Indication Approved: December 1, 2020
Date of Original Approval: June 20, 2003

Xolair (omalizumab) is an anti-IgE monoclonal antibody indicated for:
  • moderate to severe persistent asthma in patients 6 years of age and older
  • chronic idiopathic urticaria in adults and adolescents 12 years of age and older
  • nasal polyps in adult patients 18 years of age and older.

Hetlioz (tasimelteon) Capsules

New Indication Approved: December 1, 2020
Date of Original Approval: January 31, 2014

Hetlioz (tasimelteon) is a melatonin receptor agonist for the treatment of Non-24-Hour Disorder in adults, and nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older.

Xofluza (baloxavir marboxil) Tablets and Granules for Oral Suspension

New Indication Approved: November 23, 2020
Date of Original Approval: October 24, 2018

Xofluza (baloxavir marboxil) is a polymerase acidic (PA) endonuclease inhibitor for the treatment of influenza, and for the post-exposure prophylaxis of influenza in people 12 years of age and older.

Imfinzi (durvalumab) Injection

New Dosage Regimen: November 18, 2020
Date of Original Approval: May 1, 2017

Imfinzi (durvalumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated:

  • for the treatment of adult patients with unresectable, Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
  • in combination with etoposide and either carboplatin or cisplatin, as first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

Vimpat (lacosamide) Tablets, Injection, Oral Solution

New Indication Approved: November 16, 2020
Date of Original Approval: October 28, 2008

Vimpat (lacosamide) is an anti-convulsant indicated for the treatment of partial-onset seizures, and as an adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older.

Keytruda (pembrolizumab) for Injection

New Indication Approved: November 13, 2020
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, endometrial carcinoma, tumor mutational burden-high (TMB-H) cancer, cutaneous squamous cell carcinoma, and triple-negative breast cancer.

Brilinta (ticagrelor) Tablets

New Indication Approved: November 5, 2020
Date of Original Approval: July 20, 2011

Brilinta (ticagrelor) is a P2Y12 platelet inhibitor indicated:
  • to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel.
    Brilinta also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS.
  • to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of Brilinta was established in a population with type 2 diabetes mellitus (T2DM).
  • to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA).

Sklice (ivermectin) Lotion

Labeling Revision Approved: October 27, 2020
Date of Original Approval: February 7, 2012

Sklice (ivermectin) Lotion is a pediculicide indicated for the topical treatment of head lice infestations in patients 6 months of age and older.

Venclexta (venetoclax) Tablets

New Indication Approved: October 16, 2020
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.

Keytruda (pembrolizumab) for Injection

Labeling Revision Approved: October 14, 2020
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, endometrial carcinoma, tumor mutational burden-high (TMB-H) cancer, cutaneous squamous cell carcinoma, and triple-negative breast cancer.

Wakix (pitolisant) Tablets

New Indication Approved: October 13, 2020
Date of Original Approval: August 14, 2019

Wakix (pitolisant) is a histamine-3 (H₃) receptor antagonist/inverse agonist for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy.

Ultomiris (ravulizumab-cwvz) Injection

New Formulation Approved: October 9, 2020
Date of Original Approval: December 21, 2018

Ultomiris (ravulizumab-cwvz) is a long-acting C5 complement inhibitor for:

  • the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH)
  • the treatment of adults and pediatric patients one month of age and older with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA).

Opdivo (nivolumab) Injection

New Indication Approved: October 2, 2020
Date of Original Approval: December 22, 2014

Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of melanoma, non-small cell lung cancer, small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, MSI-H or dMMR metastatic colorectal cancer, hepatocellular carcinoma, and esophageal squamous cell carcinoma.

Simponi Aria (golimumab) Injection

New Indication Approved: September 30, 2020
Date of Original Approval: July 18, 2013

Simponi Aria (golimumab) is a tumor necrosis factor (TNF) blocker indicated for the treatment of:

  • Adult patients with moderately to severely active Rheumatoid Arthritis (RA) in combination with methotrexate
  • Active Psoriatic Arthritis (PsA) in patients 2 years of age and older
  • Adult patients with active Ankylosing Spondylitis (AS)
  • Active polyarticular Juvenile Idiopathic Arthritis (pJIA) in patients 2 years of age and older

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