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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