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Table 1 New Drug Applications (NDAs) Approved by the FDA between 2005 and 2014 with indications for neurologic and psychiatric conditions

From: Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study

Brand Name INN Name NDA applicant Indication Approval year
Rozerem Ramelteon Takeda Global Insomnia 2005
Chantix Varenicline tartrate Pfizer Smoking cessation 2006
Azilect Rasagiline mesylate Teva Parkinson’s disease 2006
Invega Paliperidone Janssen, L.P. Schizophrenia 2006
Vyvanse Lisdexamfetamine dimesylate New River Attention-deficit hyperactivity disorder 2007
Neupro Rotigotine Schwarz Bioscience Parkinson’s disease 2007
Pristiq Desvenlafaxine succinate Wyeth Major depressive disorder 2008
Relistor Methylnaltrexone bromide Progenics Opioid-induced constipation 2008
Xenazine Tetrabenazine Prestwick Huntington’s disease 2008
Vimpat Lacosamide Schwarz Bioscience Partial-onset seizure disorder 2008
Banzel Rufinamide Eisai Inc. Seizures associated with Lennox-Gastaut syndrome 2008
Nucynta Tapentadol Hydrochloride Ortho-McNeil-Janssen Acute pain 2008
Lusedra Fospropofol disodium Eisai Medical Anesthesia 2008
Savella Milnacipran yydrochloride Cypress Bioscience Inc. Fibromyalgia 2009
Dysport AbobotulinumtoxinA Ipsen Biopharm Limited Cervical dystonia 2009
Fanapt Iloperidone Vanda Pharmaceuticals Inc Schizophrenia 2009
Saphris Asenapine maleate Organon USA Inc. Bipolar I disorder 2009
Sabril Vigabatrin Lundbeck Inc. Complex partial seizure disorder 2009
Qutenza Capsaicin NeurogesX Inc. Neuropathic pain 2009
Ampyra Dalfampridine Acorda Therapeutics Inc. Multiple sclerosis 2010
Xeomin IncobotulinumtoxinA Merz Pharmaceuticals GmbH Cervical dystonia and blepharospasm 2010
Gilenya Fingolimod Novartis Pharmaceuticals Corp. Multiple sclerosis 2010
Latuda Lurasidone hydrochloride Sunovion Pharmaceuticals Inc. Schizophrenia 2010
Viibryd Vilazodone hydrochloride Trovis Pharmaceuticals LLC Major depressive disorder 2011
Horizant Gabapentin enacarbil Glaxo Group Ltd. DBA GlaxoSmithKline Restless legs syndrome 2011
Potiga Ezogabine GlaxoSmithKline Partial seizure disorder 2011
Onfi Clobazam Lundbeck Inc. Seizures associated with Lennox-Gastaut syndrome 2011
Aubagio Teriflunomide Sanofi Aventis US LLC Multiple sclerosis 2012
Fycompa Perampanel Eisai Inc. Partial seizure disorder 2012
Tecfidera Dimethyl fumarate Biogen Idec INC Multiple sclerosis 2013
Trintellix (formerly Brintellix) Vortioxetine Takeda Pharmaceuticals USA Inc. Major depressive disorder 2013
Aptiom Eslicarbazepine acetate Sunovion Pharmaceuticals Inc. Partial seizure disorder 2013
Hetlioz Tasimelteon Vanda Pharmaceuticals Inc. Non-24 h sleep-wake disorder 2014
Northera Droxidopa Chelsea Therapeutics Inc. Neurogenic orthostatic hypotension 2014
Belsomra Suvorexant MK4305 Merck Sharp & Dohme Corp. Insomnia 2014
Plegridy Peginterferon beta-1A Biogen Idec Inc. Multiple sclerosis 2014
Movantik Naloxegol AstraZeneca Pharmaceuticals LP Opiod-induced constipation 2014
  1. INN international nonproprietary name
  2. Please refer to the drug label for full description of each drug indication