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New drugs approved in 2013.

  • Riociguat is a stimulator to help arteries relax to increase blood flow and decrease blood pressure. It is specifically indicated for persistent/recurrent Chronic Thromboembolic Pulmonary Hypertension. 
  • Trametinib is an orally bio-available inhibitor of mitogen-activated protein kinase with potential antineoplastic activity. 
  • Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor to reduce blood glucose levels by increasing the amount of glucose excreted in the urine. 
  • Tocilizumab is a humanized anti IL-6 receptor monoclonal antibody.  specifically approved for patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis.
  • Canakinumab is a human monoclonal anti-human IL-1ß antibody. specifically indicated for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older.
  • Dimethyl fumarate is an oral, small molecule immune modulator. it has the potential to reduce the activity and impact of inflammatory cells on the central nervous system (CNS) and induce direct cytoprotective responses in CNS cells. It is specifically indicated for the treatment of adults with relapsing forms of multiple sclerosis.
  • Pomalidomide is an immunomodulatory antineoplastic agent. It inhibits proliferation and induces apoptosis of hematopoietic tumor cells, enhances T cell- and natural killer cell-mediated immunity and inhibits production of pro-inflammatory cytokines by monocytes. It is specifically indicated for patients with multiple myeloma. 
  • Lenalidomide, a thalidomide analogue, is an immunomodulatory agent with anti-angiogenic and anti-neoplastic properties. It is specifically indicated for the treatment of patients with mantle cell lymphoma (MCL). 
  • Telavancin is a semisynthetic, lipoglycopeptide antibiotic.  specifically indicated for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP), caused by susceptible isolates of Staphylococcus aureus (including methicillin-susceptible and -resistant isolates). 
  • Cysteamine bitartrate delayed-release capsules is a cystine depleting agent which lowers the cystine content of cells in patients with nephropathic cystinosis, an inherited defect of lysosomal transport. It is specifically indicated for the management of nephropathic cystinosis in adults and children ages 6 years and older.
  • Levomilnacipran is an extended release selective norepinephrine and serotonin reuptake inhibitor. It is specifically indicated for the treatment of Major Depressive Disorder.
  • Afatinib is a tyrosine kinase inhibitor. specifically indicated for the first-line treatment of patients with metastatic non-small cell lung cancer. 
  • Regorafenib  specifically indicated for patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor who have been previously treated with imatinib mesylate and sunitinib malate.
  • Vortioxetine is a serotonin modulator and stimulator. It is specifically indicated for Major Depressive Disorder.
  • Once daily topical gel formulation of brimonidine, an alpha-2 adrenergic agonist with potent vasoconstrictive activity is specifically indicated for the topical treatment of persistent (nontransient) erythema of rosacea in adults 18 years of age or older.
  • Dabrafenib is specifically indicated for the treatment of patients with unresectable or metastatic melanoma. But It is not indicated for treatment of patients with wild-type BRAF melanoma.
  • A gel formulation of mechlorethamine, an alkylating agent which inhibits rapidly proliferating cells is specifically indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy. 
  • Denosumab is a human IgG2 monoclonal antibody, specifically indicated for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
  • Radium Ra 223 dichloride, an alpha particle-emitting pharmaceutical, is a radiotherapeutic drug. It is specifically indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.
  • Dolutegravir is an integrase inhibitor. It blocks HIV replication by preventing viral DNA from integrating into the genetic material of human immune cells (T-cells). It is specifically indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and children aged 12 years and older and weighing at least 40 kg.

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