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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