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.
Simponi (golimumab) Injection
Date of Approval: April 24, 2009
Simponi (golimumab) is a human anti-tumor necrosis factor (TNF)-alpha monoclonal antibody for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis.
New Indication Approved: May 15, 2013
Ilaris (canakinumab)
Date of Approval: June 17, 2009
Ilaris (canakinumab) is a human monoclonal antibody for the treatment of children and adults with cryopyrin-associated periodic syndrome (CAPS), and for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older.
New Indication Approved: May 10, 2013
Sustiva (efavirenz )
Date of Approval: September 17, 1998
Sustiva (efavirenz) is non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for the treatment of HIV-1 infection.
Patient Population Altered: May 3, 2013
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 the treatment of active systemic juvenile idiopathic arthritis (SJIA) and polyarticular juvenile idiopathic arthritis (PJIA) in patients two years of age and older.
New Indication Approved: April 30, 2013
Plan B One-Step (levonorgestrel) Tablet
Date of Approval: July 10, 2009
Plan B One-Step (levonorgestrel) is a single dose emergency contraceptive pill to help prevent an unintended pregnancy after unprotected sex or contraceptive failure. Plan B One-Step will be available over-the-counter (OTC) for consumers age 17 or older; women younger than age 17 will require a prescription.
Patient Population Altered: April 30, 2013
Amitiza (lubiprostone) Capsules
Date of Approval: January 31, 2006
Amitiza (lubiprostone) is a selective chloride channel activator for the treatment of chronic idiopathic constipation and opioid-induced constipation in adults, and irritable bowel syndrome with constipation in adult women.
New Indication Approved: April 19, 2013
Topicort (desoximetasone)
Date of Approval: February 28, 1977
Topicort (desoximetasone) is a topical corticosteroid indicated for the relief of inflammatory skin conditions.
New Formulation Approved: April 11, 2013
Aciphex (rabeprazole)
Date of Approval: August 19, 1999
Aciphex (rabeprazole) is a proton-pump inhibitor indicated for the treatment of gastroesophageal reflux disease (GERD) and other conditions involving excessive stomach acid.
New Formulation Approved: March 26, 2013
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.
New Formulation Approved: February 28, 2013
Stivarga (regorafenib) Tablets
Date of Approval: September 27, 2012
Stivarga (regorafenib) is an oral multi-kinase inhibitor for the treatment of patients with metastatic colorectal cancer, and gastrointestinal stromal tumors.
New Indication Approved: February 25, 2013
Epiduo (adapalene and benzoyl peroxide) Gel
Date of Approval: December 8, 2008
Epiduo (adapalene and benzoyl peroxide) Gel is a once-daily, topical retinoid and antimicrobial combination for the treatment of acne.
Patient Population Altered: February 1, 2013
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: January 25, 2013
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.
Patient Population Altered: January 25, 2013
Exjade (deferasirox) Dispersible Tablets
Date of Approval: November 2, 2005
Exjade (deferasirox) is a once-daily oral iron chelator approved for the treatment of chronic iron overload due to blood transfusions, and non-transfusion-dependent thalassemia.
New Indication Approved: January 23, 2013
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, urinary incontinence in people with neurologic conditions, and overactive bladder.
New Indication Approved: January 18, 2013
Tamiflu (oseltamivir)
Date of Approval: October 27, 1999
Tamiflu (oseltamivir) is an influenza neuraminidase inhibitor indicated for the treatment and prevention of influenza.
Patient Population Altered: December 21, 2012
Kineret (anakinra) Injection
Date of Approval: November 14, 2001
Kineret (anakinra) is an interleukin-1 receptor antagonist indicated for the treatment of rheumatoid arthritis and neonatal-onset multisystem inflammatory disease (NOMID).
New Indication Approved: December 21, 2012
Fluarix (influenza virus vaccine, inactivated)
Date of Approval: August 31, 2005
Fluarix (influenza virus vaccine, inactivated) is an influenza virus vaccine indicated for adults and children (3 years and older) for the prevention of influenza disease.
New Formulation Approved: December 17, 2012
Zytiga (abiraterone) Tablets
Date of Approval: April 28, 2011
Zytiga (abiraterone acetate) is a CYP17 inhibitor indicated for the treatment of patients with metastatic castration-resistant prostate cancer.
New Indication Approved: December 10, 2012
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.
New Indication Approved: November 16, 2012
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, to reduce the risk of stroke in people who have abnormal heart rhythm (non-valvular atrial fibrillation) and to treat and reduce the risk of deep vein thrombosis (DVT) or pulmonary embolism (PE)
New Indication Approved: November 2, 2012
Abraxane (paclitaxel protein-bound) for Injectable Suspension
Date of Approval: January 7, 2005
Abraxane (paclitaxel protein-bound) is an albumin-bound form of the antineoplastic agent paclitaxel indicated for the treatment of breast cancer and non-small cell lung cancer.
New Indication Approved: October 11, 2012
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, and ulcerative colitis.
New Indication Approved: September 28, 2012
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, bone loss in patients with prostate or breast cancer undergoing hormone ablation therapy, and to increase bone mass in men with osteoporosis at high risk for fracture.
New Indication Approved: September 21, 2012
Exelon (rivastigmine) Capsules, Oral Solution and Transdermal Patch
Date of Approval: April 21, 2000
Exelon (rivastigimine) is an acetylcholinesterase inhibitor indicated for the treatment of mild to moderate Alzheimer's dementia and dementia associated with Parkinson’s disease.
New Formulation Approved: August 31, 2012
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 kidney cancer, subependymal giant cell astrocytoma (SEGA) and renal angiomyolipomas associated with tuberous sclerosis, pancreatic neuroendocrine tumors and advanced breast cancer.
New Dosage Form Approved: August 29, 2012
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 Indication Approved: August 28, 2012
Exalgo (hydromorphone) Extended Release Tablets
Date of Approval: March 1, 2010
Exalgo (hydromorphone) is a once-a-day extended release opioid formulation for the management of moderate to severe pain in opioid-tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.
New Dosage Form Approved: August 27, 2012
Tradjenta (linagliptin) Tablets
Date of Approval: May 2, 2011
Tradjenta (linagliptin) is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Labeling Revision Approved: August 13, 2012
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, and diabetic macular edema.
New Indication Approved: August 10, 2012
Suboxone (buprenorphine and naloxone)
Date of Approval: October 8, 2002
Suboxone (buprenorphine and naloxone) is an opioid analgesic and opioid antagonist combination indicated for the treatment of opioid dependence.
New Formulation Approved: August 10, 2012
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 kidney cancer, subependymal giant cell astrocytoma (SEGA) and renal angiomyolipomas associated with tuberous sclerosis, pancreatic neuroendocrine tumors and advanced breast cancer.
New Indication Approved: July 20, 2012
Truvada (emtricitabine and tenofovir) Tablets
Date of Approval: August 2, 2004
Truvada (emtricitabine and tenofovir disoproxil fumarate) is a combination of nucleoside analog HIV-1 reverse transcriptase inhibitors indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.
New Indication Approved: July 16, 2012
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 Indication Approved: June 25, 2012
Lyrica (pregabalin) Capsules
Date of Approval: December 30, 2004
Lyrica (pregabalin) is a structural derivative of the inhibitory neurotransmitter gamma aminobutyric acid indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia and spinal cord injury; as an adjunctive therapy for partial onset seizures and for the treatment of fibromyalgia.
New Indication Approved: June 20, 2012
Horizant (gabapentin enacarbil) Extended Release Tablets
Date of Approval: April 6, 2011
Horizant (gabapentin enacarbil) is a gabapentin prodrug indicated for the once-daily treatment of restless legs syndrome and postherpetic neuralgia.
New Indication Approved: June 6, 2012
Levemir (insulin detemir ) Injection
Date of Approval: June 16, 2005
Levemir (insulin detemir) is a novel, long- acting form of insulin that provides up to a 24-hour duration of action for the treatment of diabetes mellitus (type 1 and type 2).
Patient Population Altered: May 18, 2012
Levaquin (levofloxacin)
Date of Approval: December 20, 1996
Levaquin (levofloxacin) is a fluoroquinolone antibacterial indicated for the treatment of pneumonia, bacterial sinusitis, bronchitis, skin and skin structure infections, bacterial prostatitis, urinary tract infections, pyelonephritis, inhalational anthrax, and plague.
New Indication Approved: April 27, 2012
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 kidney cancer, subependymal giant cell astrocytoma (SEGA) and renal angiomyolipomas associated with tuberous sclerosis, pancreatic neuroendocrine tumors and advanced breast cancer.
Labeling Revision Approved: April 26, 2012
Votrient (pazopanib) Tablets
Date of Approval: October 19, 2009
Votrient (pazopanib) is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma and advanced soft tissue sarcoma.
New Indication Approved: April 26, 2012
Victoza (liraglutide) Injection
Date of Approval: January 25, 2010
Victoza (liraglutide) 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.
Labeling Revision Approved: April 6, 2012
Neupro (rotigotine) Transdermal System
Date of Approval: May 9, 2007
Neupro (rotigotine) is a dopamine agonist transdermal system indicated for the treatment of Parkinson’s disease and Restless Legs Syndrome.
New Indication Approved: April 2, 2012
Levemir (insulin detemir ) Injection
Date of Approval: June 16, 2005
Levemir (insulin detemir) is a novel, long- acting form of insulin that provides up to a 24-hour duration of action for the treatment of diabetes mellitus (type 1 and type 2).
Labeling Revision Approved: March 29, 2012
Intelence (etravirine) Tablets
Date of Approval: January 18, 2008
Intelence (etravirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.
Patient Population Altered: March 26, 2012
Natazia (dienogest and estradiol valerate)
Date of Approval: May 6, 2010
Natazia (dienogest and estradiol valerate) is a combination oral contraceptive indicated for use by women to prevent pregnancy and to treat heavy menstrual bleeding.
New Indication Approved: March 14, 2012
FluMist (Influenza Virus Vaccine, Live, Intranasal)
Date of Approval: June 17, 2003
FluMist is a live trivalent nasally administered vaccine intended for active immunization for the prevention of influenza.
New Formulation Approved: March 1, 2012
Angeliq (drospirenone and estradiol) Tablets
Date of Approval: September 28, 2005
Angeliq is a hormone replacement therapy containing estradiol and the progestin drospirenone, a hormone that counters the excess water and sodium buildup that is a side effect of estradiol. Angeliq is used to treat moderate to severe menopausal symptoms, such as hot flashes and vaginal dryness.
New Formulation Approved: February 29, 2012
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
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