New Molecular Entities Approved In 2013

Annual listing of novel drugs cleared by FDA’s Center for Drug Evaluation and Research.

Product And Sponsor	Indication	Date Approved (Application Number)
Nesina Alogliptin Takeda Pharmaceuticals U.S.A. Inc.	Dipeptidyl peptidase-4 inhibitor as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [Editor’s note: FDA approved single-agent alogliptin first, followed the same day by approval in combination with metformin (Kazano) and with pioglitazone (Oseni)]	1/25/2013 (22-271) (S)
Kynamro Mipomersen Genzyme Corp. (Sanofi)	Oligonucleotide inhibitor of apolipoprotein B-100 synthesis as an adjunct to lipid-lowering medications and diet to reduce low-density lipoprotein-cholesterol (LDL-C), apolipoprotein B (apo B), total cholesterol and non-high-density lipoprotein-cholesterol (non-HDL-C) in patients with homozygous familial hypercholesterolemia	1/29/2013 (203568) (S)
Pomalyst Pomalidomide Celgene Corp.	Thalidomide analog for treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and bortezomib, and have demonstrated progression on or within 60 days of completion of the last therapy	2/8/2013 (204026) (S, H)
Osphena Ospemifene Shionogi Inc.	Estrogen agonist/antagonist for treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause	2/26/2013 (203505) (S)
Lymphoseek Technetium Tc 99m tilmanocept Navidea Biopharmaceuticals Inc.	Receptor-targeted radioactive diagnostic imaging agent for lymphatic mapping with a handheld gamma counter to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma	3/13/2013 (202207) (S)
Dotarem Gadoterate meglumine Guerbet SA	Gadolinium-based contrast agent for use with magnetic resonance imaging in brain (intracranial), spine and associated tissues in adult and pediatric patients (from 2 years of age and older) to detect and visualize areas with disruption of the blood brain barrier and/or abnormal vascularity	3/20/2013 (204781) (P)
Tecfidera Dimethyl fumarate, delayed-release Biogen Idec	Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway activator for treatment of patients with relapsing forms of multiple sclerosis	3/27/2013 (204063) (S)
Invokana Canagliflozin Johnson & Johnson (Janssen Pharmaceuticals Inc.)	Sodium-glucose co-transporter 2 inhibitor as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes	3/29/2013 (204042) (S)
Breo Ellipta Vilanterol/fluticasone furoate GlaxoSmithKline	Long-acting beta2-adrenergic agonist and corticosteroid formulated as a powder for inhalation for long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease and for reduction of COPD exacerbations	5/10/2013 (204275) (S)
Xofigo Radium Ra 223 dichloride Bayer HealthCare/Algeta	Alpha particle-emitting radioactive therapeutic agent for treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease	5/15/2013 (203971) (P)
Mekinist Trametinib GlaxoSmithKline	MEK inhibitor for treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, who have not received prior BRAF inhibitor therapy	5/29/2013 (204114) (S)
Tafinlar Dabrafenib GlaxoSmithKline	BRAF inhibitor for treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutations as detected by an FDA-approved test	5/29/2013 (202806) (S)
Gilotrif Afatinib Boehringer Ingelheim	Kinase inhibitor for first-line treatment of metastatic non-small cell lung cancer patients with epidermal growth factor receptor exon 19 deletion or exon 21 (L858R) substitution mutations as detected by an FDA-approved test	7/12/2013 (201292) (P)
Tivicay Dolutegravir Viiv Healthcare	HIV-1 integrase strand transfer inhibitor for use in combination antiretroviral regimens for treatment of HIV-1 infection in adults and children aged 12 years and older who weigh at least 40 kg	8/12/2013 (204790) (P)
Brintellix Vortioxetine Takeda Pharmaceuticals	Multimodal antidepressant for treatment of major depressive disorder	9/3/2013 (204447) (S)
Duavee Bazedoxifene/conjugated estrogens Pfizer	Estrogen agonist/antagonist combined with conjugated estrogens for treatment of moderate to severe vasomotor symptoms associated with menopause and prevention of postmenopausal osteoporosis in women with a uterus	10/3/2013 (022247) (S)
Adempas Riociguat Bayer HealthCare	Oral soluble guanylate cyclase stimulator for treatment of persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) (WHO Group 4) after surgical treatment or inoperable CTEPH to increase exercise capacity and WHO functional class and for treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to increase exercise capacity, WHO functional class, and to delay clinical worsening	10/8/2013 (204819) (P)
Opsumit Macitentan Actelion Pharmaceuticals	Endothelin receptor antagonist for treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to delay disease progression, including death, initiation of I.V. or subcutaneous prostanoids, or clinical worsening of PAH (decreased 6-minute walk distance, worsened PAH symptoms and need for additional PAH treatment), and to reduce hospitalization for PAH	10/18/2013 (204410) (S)
Vizamyl Flutemetamol F 18 GE Healthcare	Radioactive diagnostic agent for Positron Emission Tomography (PET) imaging of the brain to estimate beta amyloid neuritic plaque density in adult patients who are being evaluated for Alzheimer’s disease or other causes of cognitive decline as an adjunct to other diagnostic evaluations	10/25/2013 (203137) (S)
Aptiom Eslicarbazepine acetate Sunovion Pharmaceuticals	Voltage-gated sodium channel inhibitor anti-epileptic drug as add-on treatment for partial onset seizures associated with epilepsy	11/8/2013 (022416) (S)
Imbruvica Ibrutinib Pharmacyclics/J&J (Janssen Biotech)	Bruton’s tyrosine kinase inhibitor for treatment of patients with mantle cell lymphoma who have received at least one prior therapy	11/13/2013 (205552) (P, H, V, B)
Luzu Luliconazole Valeant Pharmaceuticals (Medicis)	Azole antifungal for topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum and Epidermophyton floccosum in patients 18 years of age and older	11/14/2013 (204153) (S)
Olysio Simeprevir J&J (Janssen R&D)	Hepatitis C virus NS3/4A protease inhibitor for once-daily oral use in combination with pegylated interferon and ribavirin for treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease	11/22/2013 (205123) (P)
Sovaldi Sofosbuvir Gilead Sciences	Oral hepatitis C virus nucleotide analog NS5B polymerase inhibitor for once-daily treatment of chronic hepatitis C virus infection in combination with ribavirin as all-oral therapy for patients with genotype 2 and 3 HCV infection and in combination with ribavirin and pegylated interferon for use in treatment-naïve patients with genotype 1 and 4 HCV infection	12/6/2013 (204671) (P, B)
Ellipta (Umeclidinium/vilanterol powder for inhalation) GlaxoSmithKline	Fixed-dose combination of the inhaled long-acting muscarinic antagonist and long-acting beta agonist (vilanterol is approved in combination with fluticasone as Breo) delivered by the Ellipta dry powder inhaler for long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema	12/18/2013 (203-975) (S)
S: Standard review P: Priority review V: Orphan drug H: Accelerated approval B: Breakthrough Therapy