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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.

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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