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.
Janumet (metformin and sitagliptin) Tablets
Date of Approval: March 30, 2007
Janumet is a combination of the oral antihyperglycemic drugs sitagliptin and metformin indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus.
New Formulation Approved: February 2, 2012
Gleevec (imatinib mesylate) Tablets
Date of Approval: May 10, 2001
Gleevec (imatinib mesylate) is a kinase inhibitor indicated for the treatment of chronic myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic/ myeloproliferative diseases, mastocytosis, dermatofibrosarcoma protuberans and gastrointestinal stromal tumors.
New Indication Approved: January 31, 2012
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). Vyvanse was developed to lower abuse potential by remaining therapeutically inactive until metabolized in the body.
New Indication Approved: January 31, 2012
Vytorin (ezetimibe/simvastatin) Tablets
Date of Approval: July 23, 2004
Vytorin (ezetimibe/simvastatin) is a combination of ezetimibe (a lipid-lowering compound) and simvastatin (an HMG-CoA reductase inhibitor) for the treatment of high LDL cholesterol (LDL-C) in patients with primary hypercholesterolemia or mixed hyperlipidemia as adjunctive therapy to diet when diet alone is not enough.
Labeling Revision Approved: January 24, 2012
Velcade (bortezomib) for Injection
Date of Approval: May 13, 2003
Velcade is an antineoplastic agent indicated for the treatment of multiple myeloma and mantle cell lymphoma.
New Dosage Regimen: January 23, 2012
Viread (tenofovir disoproxil fumarate) Tablets
Date of Approval: October 26, 2001
Viread (tenofovir disoproxil fumarate) is a nucleoside reverse transcriptase inhibitor (NRTI) for the treatment of HIV infection in adults and pediatric patients 2 years of age and older, and chronic hepatitis B in adults.
Patient Population Altered: January 18, 2012
Adcetris (brentuximab vedotin) Injection
Date of Approval: August 19, 2011
Adcetris (brentuximab vedotin) is a CD30-directed antibody-drug conjugate (ADC) indicated for the treatment of relapsed or refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma (ALCL).
Labeling Revision Approved: January 13, 2012
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 in infants, young children and adults ages 50 and older.
Patient Population Altered: December 30, 2011
Berinert (C1 esterase inhibitor (human)) Injection
Date of Approval: October 9, 2009
Berinert (C1-esterase inhibitor (human)) is a plasma derived C1 esterase inhibitor indicated for the treatment of acute abdominal, facial, or laryngeal attacks of hereditary angioedema (HAE) in adult and adolescent patients.
New Indication Approved: December 22, 2011
Isentress (raltegravir) Tablets
Date of Approval: October 12, 2007
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: December 21, 2011
Keppra (levetiracetam)
Date of Approval: November 30, 1999
Keppra is an antiepileptic drug used to treat partial onset seizures in people with epilepsy. It is also used to treat myoclonic seizures and tonic-clonic seizures.
Patient Population Altered: December 16, 2011
Opana (oxymorphone) Tablets and ER Tablets
Date of Approval: June 22, 2006
Opana ER (extended-release) and Opana (immediate-release) are oral formulations of the opioid analgesic oxymorphone, used for the relief of moderate-to-severe pain. Opana ER is indicated for patients requiring continuous, around-the-clock opioid treatment for an extended period of time, and Opana is indicated for the relief of acute pain where the use of an opioid is appropriate.
New Formulation Approved: December 9, 2011
Erbitux (cetuximab) Injection
Date of Approval: February 12, 2004
Erbitux is epidermal growth factor receptor (EGFR) antagonist indicated for the treatment of colorectal cancer and Head and Neck Cancer.
New Indication Approved: November 7, 2011
Xarelto (rivaroxaban) Tablets
Date of Approval: July 1, 2011
Xarelto (rivaroxaban) is a factor Xa inhibitor indicated for the prophylaxis of deep vein thrombosis (DVT) in patients undergoing knee or hip replacement surgery, and to reduce the risk of stroke in people who have abnormal heart rhythm (non-valvular atrial fibrillation).
New Indication Approved: November 4, 2011
Byetta (exenatide) Injection
Date of Approval: April 28, 2005
Byetta (exenatide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
New Dosage Regimen: October 19, 2011
Cialis (tadalafil) Tablets
Date of Approval: November 21, 2003
Cialis is a phosphodiesterase 5 (PDE5) inhibitor indicated for erectile dysfunction, and to treat the signs and symptoms of benign prostatic hyperplasia.
New Indication Approved: October 7, 2011
Combivent (albuterol and ipratropium) Inhalation Aerosol
Date of Approval: October 24, 1996
Combivent (albuterol and ipratropium) is a beta2-adrenergic bronchodilator and anticholinergic bronchodilator combination for the treatment of chronic obstructive pulmonary disease (COPD).
New Formulation Approved: October 7, 2011
Soliris (eculizumab) Injection
Date of Approval: March 16, 2007
Soliris (eculizumab) is a monoclonal antibody indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, and for the treatment of patients with atypical hemolytic uremic syndrome.
New Indication Approved: September 23, 2011
Remicade (infliximab) Injection
Date of Approval: August 24, 1998
Remicade (infliximab) is a tumor necrosis factor (TNF) blocker indicated for use in the treatment of Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.
Patient Population Altered: September 23, 2011
Prolia (denosumab) Injection
Date of Approval: June 1, 2010
Prolia is a RANK ligand (RANKL) inhibitor indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, and for the treatment of bone loss in patients with prostate or breast cancer undergoing hormone ablation therapy.
New Indication Approved: September 16, 2011
Artiss (fibrin sealant (human)) Topical Solution
Date of Approval: March 19, 2008
Artiss (fibrin sealant (human)) is a slow-setting fibrin sealant indicated for use in adhering skin grafts in adult and pediatric burn patients and for tissue adherence in facial rhytidectomy (face-lift) surgery.
New Indication Approved: August 31, 2011
Nucynta (tapentadol) Tablets
Date of Approval: November 20, 2008
Nucynta (tapentadol) is a centrally acting oral analgesic indicated for the relief of moderate to severe acute pain.
New Dosage Form Approved: August 25, 2011
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, prevention of chronic migraine and urinary incontinence in people with neurologic conditions.
New Indication Approved: August 24, 2011
Orencia (abatacept) Injection
Date of Approval: December 23, 2005
Orencia (abatacept) is a selective costimulation modulator indicated for the treatment of rheumatoid arthritis (RA).
New Formulation Approved: July 29, 2011
Gammagard Liquid (immune globulin infusion (human)) Solution
Date of Approval: May 2, 2005
Gammagard (immune globulin infusion (human)) is an immune globulin infusion (human) indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age or older.
New Dosage Form Approved: July 22, 2011
Xeomin (incobotulinumtoxinA)
Date of Approval: July 30, 2010
Xeomin (incobotulinumtoxinA) is a botulinum toxin type A for the treatment of adults with cervical dystonia, blepharospasm and glabellar lines.
New Indication Approved: July 20, 2011
Welchol (colesevelam) Tablets and Oral Suspension
Date of Approval: May 26, 2000
Welchol (colesevelam HCl) is a bile acid sequestrant indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in patients with primary hyperlipidemia, and to improve glycemic control in adults with type 2 diabetes mellitus.
Labeling Revision Approved: July 18, 2011
Zyclara (imiquimod) Cream
Date of Approval: March 25, 2010
Zyclara (imiquimod) is an immune response modifier indicated for the topical treatment of actinic keratoses and external genital warts.
New Dosage Regimen: July 15, 2011
Lialda (mesalamine) Delayed Release Tablets
Date of Approval: January 16, 2007
Lialda (mesalamine) is a locally acting 5-aminosalicylic acid (5-ASA) indicated for the induction of remission in adults with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis.
Labeling Revision Approved: July 14, 2011
Boostrix (tetanus, diphtheria, acellular pertussis vaccine (Tdap))
Date of Approval: May 3, 2005
Boostrix is a combination vaccine that provides a booster immunization against pertussis (whooping cough) in combination with tetanus and diphtheria.
Patient Population Altered: July 8, 2011
Lupron Depot (leuprolide acetate) Injection
Date of Approval: January 26, 1989
Lupron Depot is a gonadotropin releasing hormone (GnRH) agonist indicated for the palliative treatment of advanced prostatic cancer.
New Dosage Regimen: June 17, 2011
Istodax (romidepsin) for Injection
Date of Approval: November 5, 2009
Istodax (romidepsin) a histone deacetylase (HDAC) inhibitor indicated the treatment of cutaneous T-cell lymphoma and peripheral T-cell lymphoma.
New Indication Approved: June 16, 2011
Creon (pancrelipase) Delayed-Release Capsules
Date of Approval: April 30, 2009
Creon (pancrelipase) is a combination of porcine-derived lipases, proteases, and amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, pancreatectomy, or other conditions.
New Dosage Form Approved: June 10, 2011
Sutent (sunitinib malate) Capsules
Date of Approval: January 26, 2006
Sutent (sunitinib malate) is an oral multi-kinase inhibitor indicated for the treatment of patients with gastrointestinal stromal tumors, advanced kidney cancer and pancreatic neuroendocrine tumors.
New Indication Approved: May 20, 2011
Humalog (insulin lispro) Injection
Date of Approval: June 14, 1996
Humalog (insulin lispro) is a rapid acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.
Labeling Revision Approved: May 18, 2011
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: May 9, 2011
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 renal cell carcinoma, subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis and pancreatic neuroendocrine tumors.
New Indication Approved: May 6, 2011
AndroGel (testosterone) Transdermal Gel
Date of Approval: February 28, 2000
AndroGel (testosterone gel) is an androgen indicated for replacement therapy in males with hypogonadism.
New Formulation Approved: April 29, 2011
Fusilev (levoleucovorin) for Injection
Date of Approval: March 7, 2008
Fusilev (levoleucovorin calcium) is a folate analog indicated for rescue after high-dose methotrexate therapy in osteosarcoma, diminishing the toxicity and counteracting the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists, and for use in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer.
New Indication Approved: April 29, 2011
Nexium (esomeprazole)
Date of Approval: February 20, 2001
Nexium (esomeprazole) is a proton pump inhibitor indicated for the healing and maintenance of healing of erosive esophagitis, treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD), for use in combination with amoxicillin and clarithromycin for H. pylori eradication to reduce the risk of duodenal ulcer recurrence, prevention of NSAID-induced gastric ulcers and Zollinger-Ellison Syndrome.
Patient Population Altered: April 29, 2011
Lamictal XR (lamotrigine) Extended Release Tablets
Date of Approval: May 29, 2009
Lamictal XR (lamotrigine) is a once-daily antiepileptic drug indicated as adjunctive therapy for partial onset seizures with or without secondary generalization and primary generalized tonic-clonic seizures in patients 13 years of age or older. Lamictal XR is also indicated for conversion to monotherapy for the treatment of partial onset seizures.
Labeling Revision Approved: April 25, 2011
Menactra (meningococcal conjugate vaccine)
Date of Approval: January 14, 2005
Menactra (meningococcal conjugate vaccine) is a quadrivalent conjugate vaccine indicated for the prevention of meningococcal disease.
Patient Population Altered: April 22, 2011
Rituxan (rituximab) Injection for Intravenous Use
Date of Approval: November 26, 1997
Rituxan (rituximab) is a CD20-directed cytolytic antibody indicated for the treatment of patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, Wegener's granulomatosus and microscopic polyangiitis.
New Indication Approved: April 19, 2011
Actemra (tocilizumab) Injection
Date of Approval: January 8, 2010
Actemra (tocilizumab) is a humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody for the treatment of moderate to severe rheumatoid arthritis in adults and for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients two years of age and older.
New Indication Approved: April 15, 2011
Invega (paliperidone)
Date of Approval: December 19, 2006
Invega (paliperidone) is a once-daily oral atypical antipsychotic indicated for the acute and maintenance treatment of schizophrenia, and the acute treatment of schizoaffective disorder. Invega Sustenna is an extended-release injectable formulation of paliperidone administered once-monthly for the acute and maintenance treatment of schizophrenia.
Patient Population Altered: April 6, 2011
Viramune (nevirapine)
Date of Approval: June 21, 1996
Viramune (nevirapine) is an NNRTI indicated for the combination antiretroviral treatment of HIV-1 infection.
New Formulation Approved: March 25, 2011
Zostavax (zoster vaccine live) Injection
Date of Approval: May 25, 2006
Zostavax (zoster vaccine live) is a live attenuated virus vaccine indicated for prevention of herpes zoster (shingles) in individuals 50 years of age and older.
Patient Population Altered: March 24, 2011
Zyclara (imiquimod) Cream
Date of Approval: March 25, 2010
Zyclara (imiquimod) is an immune response modifier indicated for the topical treatment of actinic keratoses and external genital warts.
New Indication Approved: March 24, 2011
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.
New Dosage Form Approved: March 3, 2011
Abilify (aripiprazole)
Date of Approval: November 15, 2002
Abilify (aripiprazole) is a psychotropic drug indicated for the treatment of schizophrenia, bipolar disorder, adjunctive treatment of major depressive disorder and treatment of irritability associated with autistic disorder.
Labeling Revision Approved: February 16, 2011
See also: New Drug Approvals, New Drug Applications, Recent Additions to Drugs.com
