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.
Ilaris (canakinumab) Injection
Date of Approval: June 17, 2009
Ilaris (canakinumab) is a human anti-interleukin-1β monoclonal antibody for the treatment of Periodic Fever Syndromes (Cryopyrin-Associated Periodic Syndromes, Tumor Necrosis Factor Receptor Associated Periodic Syndrome, Hyperimmunoglobulin D Syndrome/Mevalonate Kinase Deficiency, Familial Mediterranean Fever) and active Systemic Juvenile Idiopathic Arthritis.
New Indication Approved: September 23, 2016
See approval history for Ilaris
Stelara (ustekinumab) Injection
Date of Approval: September 25, 2009
Stelara (ustekinumab) is a human monoclonal antibody for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis.
New Indication Approved: September 23, 2016
See approval history for Stelara
Invokamet (canagliflozin and metformin) Tablets
Date of Approval: August 8, 2014
Invokamet (canagliflozin/metformin) is a selective sodium glucose co-transporter 2 (SGLT2) inhibitor and biguanide combination for the treatment of type 2 diabetes.
New Dosage Form Approved: September 20, 2016
See approval history for Invokamet
Arzerra (ofatumumab) Injection
Date of Approval: October 26, 2009
Arzerra (ofatumumab) is a CD20-directed cytolytic monoclonal antibody indicated for the treatment of patients with chronic lymphocytic leukemia.
New Indication Approved: August 30, 2016
See approval history for Arzerra
Blincyto (blinatumomab) Injection
Date of Approval: December 3, 2014
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).
Patient Population Altered: August 30, 2016
See approval history for Blincyto
Afluria (influenza virus vaccine) Injection
Date of Approval: September 28, 2007
Afluria (influenza virus vaccine) is an inactivated influenza virus vaccine, indicated for active immunization of persons ages 18 years and older against influenza disease.
New Formulation Approved: August 29, 2016
See approval history for Afluria
Keytruda (pembrolizumab) for Injection
Date of Approval: September 4, 2014
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, and recurrent or metastatic head and neck squamous cell carcinoma.
New Indication Approved: August 5, 2016
See approval history for Keytruda
Dysport (abobotulinumtoxinA) Injection
Date of Approval: April 29, 2009
Dysport (abobotulinumtoxinA) is an acetylcholine release inhibitor and neuromuscular blocking agent for the treatment of cervical dystonia, for the temporary improvement in the appearance of moderate to severe glabellar lines, upper limb spasticity in adults, and lower limb spasticity in pediatric patients.
New Indication Approved: July 27, 2016
See approval history for Dysport
Relistor (methylnaltrexone bromide) Tablets and Subcutaneous Injection
Date of Approval: April 25, 2008
Relistor (methylnaltrexone) is a peripherally acting mu-opioid receptor antagonist indicated to treat opioid-induced constipation.
New Dosage Form Approved: July 19, 2016
See approval history for Relistor
Belviq (lorcaserin) Tablets
Date of Approval: June 27, 2012
Belviq (lorcaserin) is a serotonin 2C receptor agonist indicated for chronic weight management in adults who are obese, or overweight and who have at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol.
New Formulation Approved: July 15, 2016
See approval history for Belviq
Prevnar 13 (pneumococcal 13-valent conjugate vaccine)
Date of Approval: February 24, 2010
Prevnar 13 (pneumococcal 13-valent conjugate vaccine) is a vaccine indicated for active immunization against invasive pneumococcal disease.
Patient Population Altered: July 11, 2016
See approval history for Prevnar 13
Differin (adapalene)
Date of Approval: May 31, 1996
Differin (adapalene) is a retinoid product indicated for the topical treatment of acne vulgaris in patients 12 years and older.
Labeling Revision Approved: July 8, 2016
Synjardy (empagliflozin and metformin) Tablets
Date of Approval: August 26, 2015
Synjardy (empagliflozin and metformin hydrochloride) is a sodium glucose co-transporter-2 (SGLT2) inhibitor and biguanide combination for the treatment of adults with type 2 diabetes.
Patient Population Altered: July 8, 2016
See approval history for Synjardy
Repatha (evolocumab) Injection
Date of Approval: August 27, 2015
Repatha (evolocumab) is a monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) for the treatment of patients with heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia, or patients with atherosclerotic heart disease who require additional lowering of LDL-cholesterol.
New Formulation Approved: July 8, 2016
See approval history for Repatha
Xolair (omalizumab) Subcutaneous Injection
Date of Approval: June 20, 2003
Xolair (omalizumab) is a monoclonal antibody indicated for the treatment of patients with moderate to severe persistent asthma, and chronic idiopathic urticaria.
Patient Population Altered: July 7, 2016
Humira (adalimumab) Injection
Date of 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.
New Indication Approved: June 30, 2016
Prezista (darunavir) Tablets
Date of Approval: June 23, 2006
Prezista (darunavir) is a protease inhibitor used with ritonavir in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV) infection.
Patient Population Altered: June 17, 2016
See approval history for Prezista
Jentadueto (linagliptin and metformin hydrochloride) Tablets
Date of Approval: January 30, 2012
Jentadueto (linagliptin and metformin) is a dipeptidyl peptidase-4 (DPP-4) inhibitor and biguanide combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
New Formulation Approved: May 31, 2016
See approval history for Jentadueto
Teflaro (ceftaroline fosamil) Injection
Date of Approval: October 29, 2010
Teflaro (ceftaroline fosamil) is a cephalosporin antibacterial indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).
Patient Population Altered: May 27, 2016
See approval history for Teflaro
Invokamet (canagliflozin and metformin) Tablets
Date of Approval: August 8, 2014
Invokamet (canagliflozin/metformin) is a selective sodium glucose co-transporter 2 (SGLT2) inhibitor and biguanide combination for the treatment of type 2 diabetes.
Labeling Revision Approved: May 20, 2016
See approval history for Invokamet
Opdivo (nivolumab) Injection
Date of Approval: December 22, 2014
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 and classical Hodgkin lymphoma.
New Indication Approved: May 17, 2016
See approval history for Opdivo
Lenvima (lenvatinib) Capsules
Date of Approval: February 13, 2015
Lenvima (lenvatinib) is an oral multiple receptor tyrosine kinase (RTK) inhibitor for the treatment of progressive radioiodine-refractory differentiated thyroid cancer and advanced renal cell carcinoma.
New Indication Approved: May 13, 2016
See approval history for Lenvima
Vibativ (telavancin) Injection
Date of Approval: September 11, 2009
Vibativ (telavancin) is a bactericidal, once-daily injectable antibiotic for the treatment of complicated skin and skin structure infections (cSSSI), and hospital-acquired and ventilator-associated bacterial pneumonia.
Labeling Revision Approved: May 6, 2016
See approval history for Vibativ
Fycompa (perampanel) Tablets and Oral Suspension
Date of Approval: October 22, 2012
Fycompa (perampanel) is a non-competitive AMPA glutamate receptor antagonist indicated as adjunctive therapy for the treatment of partial-onset seizures and primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy.
New Dosage Form Approved: May 2, 2016
See approval history for Fycompa
Trintellix (vortioxetine) Tablets
Date of Approval: September 30, 2013
Trintellix (vortioxetine) is a multimodal antidepressant for the treatment of major depressive disorder (MDD).
Labeling Revision Approved: May 2, 2016
See approval history for Trintellix
ProAir RespiClick (albuterol sulfate) Inhalation Powder
Date of Approval: March 31, 2015
ProAir RespiClick (albuterol sulfate) is a breath-actuated, dry-powder, short-acting beta-agonist (SABA) inhaler for the relief of acute asthma symptoms.
Patient Population Altered: April 29, 2016
See approval history for ProAir RespiClick
Gadavist (gadobutrol) Injection
Date of Approval: March 14, 2011
Gadavist (gadobutrol) is a gadolinium-based contrast agent indicated for use in diagnostic magnetic resonance imaging (MRI).
New Indication Approved: April 27, 2016
See approval history for Gadavist
Gilotrif (afatinib) Tablets
Date of Approval: July 12, 2013
Gilotrif (afatinib) is a kinase inhibitor indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC).
New Indication Approved: April 15, 2016
See approval history for Gilotrif
Xalkori (crizotinib) Capsules
Date of Approval: August 26, 2011
Xalkori (crizotinib) is an oral anaplastic lymphoma kinase (ALK) inhibitor for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors are ALK-positive or ROS1-positive.
New Indication Approved: March 11, 2016
See approval history for Xalkori
Imbruvica (ibrutinib) Capsules
Date of Approval: November 13, 2013
Imbruvica (ibrutinib) is an oral Bruton's tyrosine kinase (BTK) inhibitor for the treatment of mantle cell lymphoma, chronic lymphocytic leukemia, and Waldenström’s macroglobulinemia.
New Indication Approved: March 4, 2016
See approval history for Imbruvica
Afinitor (everolimus) Tablets
Date of Approval: March 30, 2009
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: February 26, 2016
See approval history for Afinitor
Gazyva (obinutuzumab) Injection
Date of Approval: November 1, 2013
Gazyva (obinutuzumab) is a CD20-directed cytolytic antibody indicated for the combination treatment of patients with previously untreated chronic lymphocytic leukemia and follicular lymphoma.
New Indication Approved: February 26, 2016
See approval history for Gazyva
Xeljanz (tofacitinib) Tablets
Date of Approval: November 6, 2012
Xeljanz (tofacitinib) is an oral Janus kinase (JAK) inhibitor for the treatment of adult patients with moderately to severely active rheumatoid arthritis.
New Dosage Form Approved: February 24, 2016
See approval history for Xeljanz
Aczone (dapsone) Gel
Date of Approval: July 7, 2005
Aczone (dapsone) is a sulfone indicated for the topical treatment of acne vulgaris.
New Formulation Approved: February 24, 2016
See approval history for Aczone
Ibrance (palbociclib) Capsules
Date of 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.
Labeling Revision Approved: February 19, 2016
See approval history for Ibrance
Harvoni (ledipasvir and sofosbuvir) Tablets
Date of Approval: October 10, 2014
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.
New Indication Approved: February 12, 2016
See approval history for Harvoni
Daklinza (daclatasvir) Tablets
Date of Approval: July 24, 2015
Daklinza (daclatasvir) is an NS5A inhibitor indicated for use in combination with sofosbuvir for the treatment of chronic hepatitis C virus (HCV) genotype 1 or genotype 3 infection.
New Indication Approved: February 5, 2016
See approval history for Daklinza
Halaven (eribulin mesylate) Injection
Date of Approval: November 15, 2010
Halaven (eribulin mesylate) is a microtubule inhibitor indicated for the treatment of patients with metastatic breast cancer, and liposarcoma.
New Indication Approved: January 28, 2016
See approval history for Halaven
Opdivo (nivolumab) Injection
Date of Approval: December 22, 2014
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 and classical Hodgkin lymphoma.
New Indication Approved: January 23, 2016
See approval history for Opdivo
Kyprolis (carfilzomib) Injection
Date of Approval: July 20, 2012
Kyprolis (carfilzomib) is a proteasome inhibitor indicated for the treatment of patients with multiple myeloma.
New Indication Approved: January 21, 2016
See approval history for Kyprolis
Dalvance (dalbavancin) Injection
Date of Approval: May 23, 2014
Dalvance (dalbavancin) is a second generation lipoglycopeptide antibiotic for the treatment of adult patients with complicated skin and skin structure infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA).
New Dosage Regimen: January 21, 2016
See approval history for Dalvance
Botox (onabotulinumtoxinA) Injection
Date of Approval: December 9, 1991
Botox (onabotulinumtoxinA) is a neurotoxin complex indicated for the treatment of cervical dystonia, severe primary axillary hyperhidrosis (underam sweating), upper limb spasticity, lower limb spasticity, prevention of chronic migraine, urinary incontinence in people with neurologic conditions, and overactive bladder.
New Indication Approved: January 21, 2016
Cosentyx (secukinumab) Injection
Date of Approval: January 21, 2015
Cosentyx (secukinumab) is a selective interleukin-17A (IL-17A) inhibitor for the treatment of plaque psoriasis, ankylosing spondylitis, and psoriatic arthritis.
New Indication Approved: January 15, 2016
See approval history for Cosentyx
Arzerra (ofatumumab) Injection
Date of Approval: October 26, 2009
Arzerra (ofatumumab) is a CD20-directed cytolytic monoclonal antibody indicated for the treatment of patients with chronic lymphocytic leukemia.
Labeling Revision Approved: January 15, 2016
See approval history for Arzerra
Hiberix (Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)) Solution for Intramuscular Injection
Date of Approval: August 19, 2009
Hiberix is a vaccine indicated for active immunization as a booster dose for the prevention of invasive disease caused by Haemophilus influenzae type b. Hiberix is approved for use in children aged six weeks through four years of age (prior to fifth birthday).
Patient Population Altered: January 14, 2016
See approval history for Hiberix
Humulin R (insulin human) Injection
Date of Approval: October 28, 1982
Humulin R (insulin human) is a regular short-acting insulin indicated to improve glycemic control in adults and children with type 1 and type 2 diabetes mellitus.
New Dosage Form Approved: December 29, 2015
Xeomin (incobotulinumtoxinA) Injection
Date of Approval: July 30, 2010
Xeomin (incobotulinumtoxinA) is a botulinum toxin type A for the treatment of adults with cervical dystonia, blepharospasm, glabellar lines, and upper limb spasticity.
New Indication Approved: December 22, 2015
See approval history for Xeomin
Keytruda (pembrolizumab) for Injection
Date of Approval: September 4, 2014
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, and recurrent or metastatic head and neck squamous cell carcinoma.
New Indication Approved: December 18, 2015
See approval history for Keytruda
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant) Injection
Date of Approval: December 10, 2014
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant) is a 9-valent HPV vaccine for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58.
Patient Population Altered: December 15, 2015
See approval history for Gardasil 9
Opdivo (nivolumab) Injection
Date of Approval: December 22, 2014
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 and classical Hodgkin lymphoma.
New Indication Approved: November 23, 2015
See approval history for Opdivo
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