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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.

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: July 24, 2015

See complete approval history for Kyprolis

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, and for the treatment of upper limb spasticity.

New Indication Approved: July 16, 2015

See complete approval history for Dysport

Iressa (gefitinib) Tablets

Date of Approval: May 5, 2003

Iressa (gefitinib) is a tyrosine kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have specific epidermal growth factor receptor (EGFR) gene mutations as detected by an FDA-approved test.

New Indication Approved: July 13, 2015

Fycompa (perampanel) Tablets

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 Indication Approved: June 19, 2015

See complete approval history for Fycompa

Promacta (eltrombopag) Tablets

Date of Approval: November 20, 2008

Promacta (eltrombopag) is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura.

Patient Population Altered: June 12, 2015

See complete approval history for Promacta

Zomig Nasal Spray (zolmitriptan)

Date of Approval: September 30, 2003

Zomig (zolmitriptan) Nasal Spray is a serotonin (5-HT)1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine.

Patient Population Altered: June 12, 2015

Rapamune (sirolimus)

Date of Approval: August 25, 2000

Rapamune (sirolimus) is an immunosuppressive agent indicated for the prophylaxis of organ rejection in renal transplant patients; and for the treatment of lymphangioleiomyomatosis (LAM), a rare, progressive lung disease.

New Indication Approved: May 28, 2015

Xifaxan (rifaximin) Tablets

Date of Approval: May 25, 2004

Xifaxan (rifaximin) is a nonsystemic antibiotic indicated for the treatment of patients with traveler's diarrhea caused by noninvasive strains of Escherichia coli, to reduce the risk of recurrence of hepatic encephalopathy in patients with advanced liver disease, and for the treatment of irritable bowel syndrome with diarrhea (IBS-D).

New Indication Approved: May 27, 2015

See complete approval history for Xifaxan

Treximet (sumatriptan succinate and naproxen sodium) Tablets

Date of Approval: April 15, 2008

Treximet is a combination of sumatriptan (a migraine-specific triptan) and naproxen (an anti-inflammatory pain reliever) in a single tablet for the acute treatment of migraine.

Patient Population Altered: May 15, 2015

See complete approval history for Treximet

Avelox (moxifloxacin) Tablets and Injection

Date of Approval: December 10, 1999

Avelox (moxifloxacin) is a fluoroquinolone antibacterial indicated for the treatment of acute bacterial sinusitis, bronchitis, pneumonia, skin and skin structure infections, complicated intra-abdominal Infections and plague.

New Indication Approved: May 8, 2015

Breo Ellipta (fluticasone and vilanterol) Inhalation Powder

Date of Approval: May 10, 2013

Breo Ellipta (fluticasone and vilanterol) is a once-a-day inhaled corticosteroid/long-acting beta2 agonist (LABA) combination indicated for the treatment of patients with chronic obstructive pulmonary disease (COPD) and asthma.

New Indication Approved: April 30, 2015

See complete approval history for Breo Ellipta

Cyramza (ramucirumab) Injection

Date of Approval: April 21, 2014

Cyramza (ramucirumab) is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated for the treatment of advanced gastric cancer and non-small cell lung cancer.

New Indication Approved: April 24, 2015

See complete approval history for Cyramza

Aggrastat (tirofiban hydrochloride) Injection

Date of Approval: May 14, 1998

Aggrastat (tirofiban hydrochloride) is a glycoprotein IIb/IIIa inhibitor antiplatelet drug indicated to reduce the rate of thrombotic cardiovascular events.

New Dosage Regimen: April 21, 2015

Minocin (minocycline) Injection

Date of Approval: October 26, 1972

Minocin (minocycline) is a tetracycline derivative indicated for the treatment of infections due to susceptible strains of designated microorganisms, including Acinetobacter species bacteria.

New Formulation Approved: April 17, 2015

Qudexy XR (topiramate) Extended-Release Capsules

Date of Approval: March 11, 2014

Qudexy XR (topiramate) is an antiepileptic drug indicated for the treatment of partial onset seizures, primary generalized tonic-clonic seizures, and Lennox-Gastaut Syndrome.

Patient Population Altered: March 31, 2015

See complete approval history for Qudexy XR

Brilinta (ticagrelor) Tablets

Date of Approval: July 20, 2011

Brilinta (ticagrelor) is a P2Y12 platelet inhibitor indicated to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome.

Labeling Revision Approved: March 26, 2015

See complete approval history for Brilinta

Eylea (aflibercept) Injection

Date of Approval: November 18, 2011

Eylea (aflibercept) is a VEGF inhibitor indicated for the treatment of patients with neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.

New Indication Approved: March 25, 2015

See complete approval history for Eylea

Kalydeco (ivacaftor) Tablets

Date of Approval: January 31, 2012

Kalydeco (ivacaftor) is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator indicated for the treatment of cystic fibrosis (CF) in patients age 2 years and older who have the G551D or R117H mutations in the CFTR gene.

New Dosage Form Approved: March 17, 2015

See complete approval history for Kalydeco

Viibryd (vilazodone) Tablets

Date of Approval: January 21, 2011

Viibryd (vilazodone) is a dual-acting potent and selective serotonin reuptake inhibitor and a 5-HT1A receptor partial agonist indicated for the treatment of major depressive disorder (MDD).

New Dosage Regimen: March 16, 2015

See complete approval history for Viibryd

Saphris (asenapine) Sublingual Tablets

Date of Approval: August 13, 2009

Saphris (asenapine) is an atypical antipsychotic for the treatment of schizophrenia and acute mania or mixed episodes associated with bipolar I disorder.

Patient Population Altered: March 13, 2015

See complete approval history for Saphris

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 and non-small cell lung cancer.

New Indication Approved: March 4, 2015

See complete approval history for Opdivo

Revlimid (lenalidomide) Capsules

Date of Approval: December 27, 2005

Revlimid (lenalidomide) is an immunomodulatory drug indicated for the treatment of patients with multiple myeloma, transfusion-dependent anemia due myelodysplastic syndromes (MDS), and mantle cell lymphoma.

New Indication Approved: February 17, 2015

See complete approval history for Revlimid

Banzel (rufinamide)

Date of Approval: November 14, 2008

Banzel (rufinamide) is a triazole derivative antiepileptic drug for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome.

Patient Population Altered: February 12, 2015

See complete approval history for Banzel

Lucentis (ranibizumab) Injection

Date of Approval: June 30, 2006

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, and diabetic retinopathy.

New Indication Approved: February 6, 2015

See complete approval history for Lucentis

Vyvanse (lisdexamfetamine dimesylate) Capsules

Date of Approval: February 23, 2007

Vyvanse (lisdexamfetamine dimesylate) is an amphetamine derivative prodrug administered once-daily for the treatment of attention deficit hyperactivity disorder (ADHD) and binge-eating disorder.

New Indication Approved: January 30, 2015

See complete approval history for Vyvanse

Zohydro ER (hydrocodone) Extended-Release Capsules

Date of Approval: October 25, 2013

Zohydro ER (hydrocodone) is a single-entity (without acetaminophen) extended-release opioid analgesic for around-the-clock management of moderate to severe chronic pain.

New Formulation Approved: January 30, 2015

See complete approval history for Zohydro ER

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: January 29, 2015

See complete approval history for Imbruvica

Kalydeco (ivacaftor) Tablets

Date of Approval: January 31, 2012

Kalydeco (ivacaftor) is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator indicated for the treatment of cystic fibrosis (CF) in patients age 2 years and older who have the G551D or R117H mutations in the CFTR gene.

New Indication Approved: December 29, 2014

See complete approval history for Kalydeco

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).

Patient Population Altered: December 29, 2014

See complete approval history for Gadavist

Bellafill (dermal filler) Injection

Date of Approval: October 27, 2006

Bellafill is a dermal filler indicated for the correction of nasolabial folds (smile lines) and for the treatment of acne scars.

New Indication Approved: December 23, 2014

See complete approval history for Bellafill

Erwinaze (asparaginase Erwinia chrysanthemi) Injection

Date of Approval: November 18, 2011

Erwinaze (asparaginase Erwinia chrysanthemi) is an antineoplastic agent used to treat patients with acute lymphoblastic leukemia (ALL) who have developed an allergy (hypersensitivity) to E. coli derived asparaginase and pegapargase chemotherapy drugs.

New Dosage Regimen: December 19, 2014

See complete approval history for Erwinaze

Granix (tbo-filgrastim) Injection

Date of Approval: August 29, 2012

Granix (tbo-filgrastim) is a leukocyte growth factor indicated for the reduction in the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs.

New Dosage Regimen: December 19, 2014

See complete approval history for Granix

QNASL (beclomethasone dipropionate) Nasal Aerosol

Date of Approval: March 23, 2012

QNASL (beclomethasone dipropionate) is an intranasal corticosteroid non-aqueous "dry" spray formulation for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR).

New Formulation Approved: December 17, 2014

See complete approval history for QNASL

Somatuline Depot (lanreotide acetate) Injection

Date of Approval: August 30, 2007

Somatuline Depot (lanreotide) is a long acting somatostatin analogue indicated for the treatment of acromegaly and gastroenteropancreatic neuroendocrine tumors.

New Indication Approved: December 16, 2014

See complete approval history for Somatuline Depot

Cyramza (ramucirumab) Injection

Date of Approval: April 21, 2014

Cyramza (ramucirumab) is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated for the treatment of advanced gastric cancer and non-small cell lung cancer.

New Indication Approved: December 12, 2014

See complete approval history for Cyramza

Fluzone (influenza virus vaccine, inactivated) Suspension for Intramuscular Injection

Date of Approval: September 4, 2002

Fluzone is an inactivated influenza virus vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B.

New Formulation Approved: December 12, 2014

Zubsolv (buprenorphine and naloxone) Sublingual Tablets

Date of Approval: July 3, 2013

Zubsolv (buprenorphine and naloxone) is a sublingual partial opioid agonist indicated for the maintenance treatment of opioid dependence.

New Dosage Form Approved: December 11, 2014

See complete approval history for Zubsolv

Xgeva (denosumab) Injection

Date of Approval: November 18, 2010

Xgeva (denosumab) is a RANK ligand (RANKL) inhibitor indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors, and for the treatment of giant cell tumor of the bone.

New Indication Approved: December 5, 2014

See complete approval history for Xgeva

Abilify Maintena (aripiprazole) for Extended-Release Injectable Suspension

Date of Approval: February 28, 2013

Abilify Maintena (aripiprazole) is an atypical antipsychotic indicated for the treatment of schizophrenia.

Labeling Revision Approved: December 5, 2014

See complete approval history for Abilify Maintena

Jakafi (ruxolitinib) Tablets

Date of Approval: November 16, 2011

Jakafi (ruxolitinib) is a Janus kinase (JAK) inhibitor indicated for the treatment of patients with myelofibrosis and polycythemia vera.

New Indication Approved: December 4, 2014

See complete approval history for Jakafi

Bellafill (dermal filler) Injection

Date of Approval: October 27, 2006

Bellafill is a dermal filler indicated for the correction of nasolabial folds (smile lines) and for the treatment of acne scars.

New Dosage Form Approved: December 1, 2014

See complete approval history for Bellafill

Priftin (rifapentine) Tablets

Date of Approval: June 22, 1998

Priftin (rifapentine) is a rifamycin antimycobacterial indicated for the treatment of pulmonary tuberculosis.

New Indication Approved: November 25, 2014

Auryxia (ferric citrate) Tablets

Date of Approval: September 5, 2014

Ferric Citrate is a phosphate binder indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis.

Labeling Revision Approved: November 17, 2014

See complete approval history for Auryxia

Avastin (bevacizumab) Injection

Date of Approval: February 26, 2004

Avastin (bevacizumab) is a recombinant humanized monoclonal IgG1 antibody for the treatment of metastatic colorectal cancer, non-small cell lung cancer, HER2-negative breast cancer, glioblastoma, renal cell carcinoma, and cervical cancer.

New Indication Approved: November 14, 2014

See complete approval history for Avastin

Invega Sustenna (paliperidone palmitate) Extended-Release Injectable Suspension

Date of Approval: July 31, 2009

Invega Sustenna (1-month paliperidone palmitate) is a long-acting injectable atypical antipsychotic indicated for the treatment of schizophrenia and schizoaffective disorder.

New Indication Approved: November 13, 2014

See complete approval history for Invega Sustenna

Cyramza (ramucirumab) Injection

Date of Approval: April 21, 2014

Cyramza (ramucirumab) is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated for the treatment of advanced gastric cancer and non-small cell lung cancer.

Labeling Revision Approved: November 5, 2014

See complete approval history for Cyramza

Olysio (simeprevir) Capsules

Date of Approval: November 22, 2013

Olysio (simeprevir) is a protease inhibitor for the treatment of chronic hepatitis C virus infection.

Labeling Revision Approved: November 5, 2014

See complete approval history for Olysio

Flublok (influenza vaccine, recombinant hemagglutinin) Injection

Date of Approval: January 16, 2013

FluBlok (influenza vaccine, recombinant hemagglutinin) is an influenza vaccine indicated for active immunization of adults against seasonal influenza.

Patient Population Altered: October 29, 2014

See complete approval history for Flublok

Embeda (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules

Date of Approval: August 13, 2009

Embeda is an abuse-deterrent, extended-release morphine preparation for the treatment of chronic pain.

Labeling Revision Approved: October 17, 2014

See complete approval history for Embeda

Uceris (budesonide)

Date of Approval: January 14, 2013

Uceris (budesonide) is a glucocorticosteroid indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.

New Dosage Form Approved: October 8, 2014

See complete approval history for Uceris

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