APPROVAL OF NEW MOLECULAR ENTITIES 2013

1	Nesina	Alogliptin	25-Jan-13	To improve blood sugar control in adults with type 2 diabetes.
2	Kynamro	Mipomersen sodium	29-Jan-13	To treat patients with a rare type of high cholesterol called homozygous familial hypercholesterolemia (HoFH).
3	Pomalyst	Pomalidomide	8-Feb-13	To treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs.
4	Kadcyla	Ado-trastuzumab emtansine	22-Feb-13	For patients with HER2-positive, late-stage (metastatic) breast cancer.
5	Osphena	Ospemifene	26-Feb-13	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	13-Mar-13	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	20-Mar-13	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	27-Mar-13	To treat adults with relapsing forms of multiple sclerosis (MS).
9	Invokana	canagliflozin	29-Mar-13	Used with diet and exercise, to improve glycemic control in adults with type 2 diabetes.
10	Breo Ellipta	Fluticasone furoate and vilanterol inhalation powder	10-May-13	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	15-May-13	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	29-May-13	To treat patients with melanoma whose tumors express the BRAF V600E gene mutation.
13	Mekinist	Trametinib	29-May-13	To treat patients whose tumors express the BRAF V600E or V600K gene mutations.
14	Gilotrif	Afatinib	12-Jul-13	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	12-Aug-13	To treat HIV-1 infection.
16	Brintellix	Vortioxetine	30-Sep-13	To treat adults with major depressive disorder.
17	Duavee	Conjugated estrogens/bazedoxifene	3-Oct-13	To treat moderate-to-severe hot flashes (vasomotor symptoms) associated with menopause and to prevent osteoporosis after menopause.
18	Adempas	Riociguat	8-Oct-13	To treat adults with two forms of pulmonary hypertension.
19	Opsumit	Macitentan	18-Oct-13	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	25-Oct-13	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	1-Nov-13	For use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia (CLL).
22	Aptiom	Eslicarbazepine acetate	8-Nov-13	As an add-on medication to treat seizures associated with epilepsy.
23	Imbruvica	Ibrutinib	13-Nov-13	To treat patients with mantle cell lymphoma (MCL), a rare and aggressive type of blood cancer.
24	Luzu	Luliconozole	14-Nov-13	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	22-Nov-13	To treat chronic hepatitis C virus infection.
26	Sovaldi	Sofosbuvir	6-Dec-13	To treat chronic hepatitis C virus (HCV) infection.
27	Anoro Ellipta	Umeclidinium and vilanterol inhalation powder	18-Dec-13	For the once-daily, long-term maintenance treatment of airflow  obstruction in patients with chronic obstructive pulmonary disease (COPD). NCK Pharma