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27 Oct 2014

New Drug Approved in 2013 by USFDA

No. Drug Name Active Ingredient Date What it’s used for
1 Nesina alogliptin 1/25/2013 To improve blood sugar control in adults with type 2 diabetes.
2 Kynamro mipomersen sodium 1/29/2013 To treat patients with a rare type of high cholesterol called homozygous familial hypercholesterolemia (HoFH).
3 Pomalyst pomalidomide 2/8/2013 To treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs.
4 Kadcyla ado-trastuzumab emtansine 2/22/2013 For patients with HER2-positive, late-stage (metastatic) breast cancer.
5 Osphena ospemifene 2/26/2013 To treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
6 Lymphoseek technetium Tc 99m tilmanocept 3/13/2013 A radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes.
7 Dotarem gadoterate meglumine 3/20/2013 For use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
8 Tecfidera dimethyl fumarate 3/27/2013 To treat adults with relapsing forms of multiple sclerosis (MS).
9 Invokana canagliflozin 3/29/2013 Used with diet and exercise, to improve glycemic control in adults with type 2 diabetes.
10 Breo Ellipta fluticasone furoate and vilanterol inhalation powder 5/10/2013 For the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
11 Xofigo radium Ra 223 dichloride 5/15/2013 To treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs.
12 Tafinlar dabrafenib 5/29/2013 To treat patients with melanoma whose tumors express the BRAF V600E gene mutation.
13 Mekinist trametinib 5/29/2013 To treat patients whose tumors express the BRAF V600E or V600K gene mutations.
14 Gilotrif afatinib 7/12/2013 For patients with late stage (metastatic) non-small cell lung cancer (NSCLC) whose tumors express specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test.
15 Tivicay dolutegravir 8/12/2013 To treat HIV-1 infection.
16 Brintellix vortioxetine 9/30/2013 To treat adults with major depressive disorder.
17 Duavee conjugated estrogens/bazedoxifene 10/3/2013 To treat moderate-to-severe hot flashes (vasomotor symptoms) associated with menopause and to prevent osteoporosis after menopause.
18 Adempas riociguat 10/8/2013 To treat adults with two forms of pulmonary hypertension.
19 Opsumit macitentan 10/18/2013 To treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive and debilitating disease that can lead to death or the need for lung transplantation.
20 Vizamyl flutemetamol F 18 injection 10/25/2013 A radioactive diagnostic drug for use with positron emission tomography (PET) imaging of the brain in adults being evaluated for Alzheimer’s disease (AD) and dementia.
21 Gazyva obinutuzumab 11/1/2013 For use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia (CLL).
22 Aptiom eslicarbazepine acetate 11/8/2013 As an add-on medication to treat seizures associated with epilepsy.
23 Imbruvica ibrutinib 11/13/2013 To treat patients with mantle cell lymphoma (MCL), a rare and aggressive type of blood cancer.
24 Luzu luliconozole 11/14/2013 For the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum, in patients 18 years of age and older.
25 Olysio simeprevir 11/22/2013 To treat chronic hepatitis C virus infection.
26 Sovaldi sofosbuvir 12/6/2013 To treat chronic hepatitis C virus (HCV) infection.
27 Anoro Ellipta umeclidinium and vilanterol inhalation powder 12/18/2013  For the once-daily, long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).

Ref: 1. USFDA official site

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