Clinical Trial Resource Center


Clinical Trial Resource Center

FDA Approved Drugs for Neurology

Drugs Approved in 2015

Duopa (carbidopa and levodopa) enteral suspension ; Abbvie; For the treatment of motor fluctuations in patients with advanced Parkinson's disease, Approved January 2015

Rytary (carbidopa and levodopa) extended-release capsules; Impax Labs; For the treatment of Parkinson's disease, Approved January 2015

Drugs Approved in 2014

Belsomra (suvorexant); Merck; For the treatment of insomnia, Approved August 2014

Dyloject (diclofenac sodium) Injection; Hospira; For the management of mild, moderate or severe pain, Approved December 2014

Hetlioz (tasimelteon); Vanda Pharmaceuticals; For the treatment of non-24-hour sleep-wake disorder in the totally blind, January 2014

Lemtrada (alemtuzumab); Genzyme; For the treatment of relapsing multiple sclerosis, Approved November 2014

Movantik (naloxegol); AstraZeneca; For the treatment of opiod-induced constipation in adults with chronic non-cancer pain, Approved September 2014

Namzaric (memantine hydrochloride extended-release + donepezil hydrochloride); Forest Laboratories; For the treatment of moderate to severe dementia of the Alzheimer's type, Approved December 2014

Northera (droxidopa); Chelsea Therapeutics; For the treatment of neurogenic orthostatic hypotension, Approved February 2014

Plegridy (peginterferon beta-1a); Biogen IDEC.; For the treatment of relapsing multiple sclerosis, Approved August 2014

Qudexy XR (topiramate); Upsher-Smith Laboratories; For the treatment of partial onset and primary generalized tonic-clonic seizures and Lennox-Gastaut Syndrome, Approved March 2014

Targiniq ER (oxycodone hydrochloride + naloxone hydrochloride) extended-release tablets; Purdue Pharma; For the management of severe chronic pain, Approved July 2014

Tivorbex (indomethacin); Iroko Pharmaceuticals; For the treatment of acute pain, Approved February of 2014

Xartemis XR (oxycodone hydrochloride and acetaminophen) extended release; Mallinckrodt Pharmaceuticals; For the management of acute pain, Approved March 2014

Drugs Approved in 2013

Aptiom (eslicarbazepine acetate); Sunovion Pharmaceuticals; For the adjunctive treatment of partial-onset seizures, Approved November 2013

Fetzima (levomilnacipran); Forest Laboratories; For the treatment of major depressive disorder, Approved July 2013

Nymalize (nimodipine); Arbor Pharmaceuticals; For the reduction of incidence and severity of ischemic deficits following subarachnoid hemorrhage, Approved May 2013

Trokendi XR (topiramate); Supernus Pharmaceuticals; For the treatment of partial onset, tonic-clonic and Lennox-Gastaut Syndrome seizures, Approved August 2013

Zohydro ER (hydrocodone bitartrate) Extended-Release Capsules; Zogenix; For the management of severe pain, Approved October 2013

Zubsolv (buprenorphine and naloxone); Orexo AB; For the maintenance treatment of opioid dependence, Approved July 2013

Drugs Approved in 2012

Eliquis (apixaban); Bristol-Myers Squibb; For the prevention of stroke and systemic embolism resulting from nonvalvular atrial fibrillation, Approved December 2012

Fycompa (perampanel); Eisai; For the treatment of partial-onset seizures with or without secondarily generalized seizures, Approved October 2012

Horizant (gabapentin enacarbil); GlaxoSmithKline; For the treatment of postherpetic neuralgia, Approved June 2012

Lyrica (pregabalin); Pfizer; For the treatment of neuropathic pain associated with spinal cord injury, Approved June 2012

Neupro (Rotigotine Transdermal System); UCB; For the treatment of Restless Legs Syndrome, Approved April 2012

Oxtellar XR (oxcarbazepine extended release); Supernus Pharmaceuticals; For the adjunctive therapy of partial seizures in adults and in children 6 years to 17 years of age, Approved October 2012

Quillivant XR (methylphenidate hydrochloride); NextWave Pharmaceuticals; For the treatment of Attention Deficit Hyperactivity Disorder, Approved September 2012

Subsys (fentanyl sublingual spray); Insys Therapeutics; For the treatment of breakthrough cancer pain, Approved January of 2012

Drugs Approved in 2011

Abstral (fentanyl sublingual tablets); ProStrakan; For the treatment of breakthrough cancer pain in opioid-tolerant patients, Approved January 2011

Exparel (bupivacaine liposome injectable suspension); Pacira Pharmaceuticals; For postsurgical analgesia, Approved November 2011

Gralise (gabapentin); Abbott Laboratories; For the treatment of postherpetic neuralgia, Approved February 2011

Horizant (gabapentin enacarbil); GlaxoSmithKline; For the treatment of restless legs syndrome, Approved April 2011

Intermezzo (zolpidem tartrate sublingual tablet); Transcept Pharmaceuticals; For the treatment of insomnia, Approved November 2011

Lazanda (fentanyl citrate) nasal spray; Archimedes; For the management of breakthrough cancer pain, Approved June 2011

Onfi (clobazam); Lundbeck; For the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome, Approved October 2011

Oxecta (oxycodone HCl); Pfizer; For the management of acute and chronic moderate to severe pain, Approved June 2011

Potiga (ezogabine); Valeant Pharmaceuticals; For the treatment of partial-onset seizures, Approved June 2011

Viibryd (vilazodone hydrochloride); Clinical Data; For the treatment of major depressive disorder, Approved January 2011

Drugs Approved in 2010

Ampyra (dalfampridine); Acorda; For the improvement of walking in patients with multiple sclerosis, Approved January 2010

Botox (onabotulinumtoxinA); Allergan; For the treatment of chronic migraine, Approved October 2010

Botox (onabotulinumtoxinA); Allergan; For the treatment of upper limb spasticity, Approved March 2010

Butrans (buprenorphine) Transdermal System; Purdue Pharma; moderate to severe chronic pain, Approved July 2010

Carbaglu (carglumic acid); Recordati; For the treatment of hyperammonemia, Approved March 2010

Cuvposa (glycopyrrolate); Shionogi; For the treatment of chronic severe drooling in pediatrics with neurologic conditions, Approved July 2010

Exalgo (hydromorphone hydrochloride) extended release; Alza; For the management of moderate to severe pain, Approved March 2010

Kapvay (clonidine hydrochloride); Shionogi; For the treatment of attention deficit hyperactivity disorder, Approved October 2010

Nuedexta (dextromethorphan hydrobromide and quinidine sulfate); Avanir Pharmaceuticals; For the treatment of pseudobulbar affect, Approved October 2010

Silenor (doxepin); Somaxon Pharma; For the treatment of insomnia, Approved March 2010

Sprix (ketorolac tromethamine); Roxro Pharma; For the treatment of moderate to severe pain, Approved May 2010

Vivitrol (naltrexone for extended-release injectable suspension); Alkermes; For the prevention of relapse to opioid dependence, Approved October 2010

Vpriv (velaglucerase alfa for injection); Shire Pharmaceuticals; For the treatment of type 1 Gaucher disease, Approved March 2010

Xifaxan (rifaximin); Salix Pharmaceuticals; For the treatment of hepatic encephalopathy, Approved March 2010

Drugs Approved in 2009

Axona (caprylidene); Accera; For the treatment of Alzheimer's disease, Approved March 2009

Cambia (diclofenac potassium for oral solution); Kowa Pharmaceuticals; For the treatment of migraine attacks, Approved June of 2009

Edluar (zolpidem tartrate); Orexo; For the treatment of insomnia, Approved March 2009

Embeda (morphine sulfate and naltrexone hydrochloride); King Pharmaceuticals; For the treatment of moderate to severe pain, Approved August of 2009

Extavia (Interferon beta-l b); Novartis; For the treatment of relapsing multiple sclerosis, Approved August of 2009

Intuniv (guanfacine extended-release); Shire Pharmaceuticals; For the treatment of ADHD in children and adolescents, Approved September 2009

Onsolis (fentanyl buccal); BioDelivery Sciences; For the management of breakthrough cancer pain, Approved July 2009

Qutenza (capsaicin); NeurogesX; For the treatment of neuropathic pain associated with postherpetic neuralgia, Approved November 2009

Sabril (vigabatrin); Lundbeck; For the treatment of infantile spasms and complex partial seizures, Approved August 2009

Zipsor (diclofenac potassium); Xanodyne Pharmaceuticals; For the treatment of mild to moderate acute pain, Approved June 2009

Drugs Approved in 2008

Banzel (rufinamide); Elan Pharmaceuticals; For the treatment of seizures associated with Lennox-Gastaut syndrome in pediatrics and adults, Approved November 2008

Durezol (difluprednate); Sirion Therapeutics; For the treatment of inflammation and pain associated with ocular surgery, Approved June 2008

Lusedra (fospropofol disodium); Elan Pharmaceuticals; A sedative-hypnotic agent indicated for monitored anesthesia care sedation, Approved December of 2008

Nucynta (tapentadol); Ortho-McNeil Pharmaceutical; moderate to severe acute pain, Approved November 2008

Stavzor (valproic acid delayed release); Banner Pharmacaps; For the treatment of bipolar manic disorder, seizures and migraine headaches, Approved July 2008

Vimpat (lacosamide); Schwarz Pharma; For the treatment of partial-onset seizures in adults with epilepsy, Approved October 2008

Xenazine (tetrabenazine); Prestwick Pharma; For the treatment of chorea due to Huntington's disease, Approved August 2008

Drugs Approved in 2007

Amrix (cyclobenzaprine hydrochloride extended release); Cephalon; For the treatment of muscle spasm associated with acute, painful musculoskeletal conditions, Approved February 2007

Exelon (rivastigmine tartrate); Novartis; For the treatment of Alzheimer's and Parkinson's disease-related dementia, Approved July 2007

Neupro (rotigotine); Schwarz Pharma; For the treatment of Parkinson's disease, Approved May 2007

Nuvigil (armodafinil); Cephalon; For the treatment of excessive sleepiness, Approved June 2007

Vyvanse (Lisdexamfetamine Dimesylate); New River; For the treatment of Attention-Deficit/Hyperactivity Disorder, Approved February 2007

Zingo (lidocaine hydrochloride monohydrate); Powder Pharmaceuticals; For local analgesia prior to venipuncture or peripheral intravenous cannulation, Approved August 2007

Drugs Approved in 2006

Invega (paliperidone); Janssen Pharmaceuticals; For the treatment of schizophrenia, Approved December 2006

Vivitrol (naltrexone for extended-release injectable suspension); Alkermes; For the treatment of alcohol dependence, Approved April 2006

Drugs Approved in 2005

Rozerem (ramelteon); Takeda; For the treatment of sleep-onset insomnia, Approved July, 2005

Tysabri (natalizumab); Elan Pharmaceuticals / Biogen Idec; For the treatment of relapsing forms of multiple sclerosis, Approved November 2004 -- Updated: Suspended February 2005--Updated: sBLA

Drugs Approved in 2004

Apokyn (apomorphine hydrochloride); Mylan Laboratories; For the treatment of acute, intermittent hypomobility episodes associated with advanced Parkinson’s disease, Approved April, 2004

Lunesta (eszopiclone); Sepracor; For the treatment of insomnia and sleep maintenance, Approved December 2004

Lyrica (pregabalin); Pfizer; For the treatment of pain associated with diabetic peripheral neuropathy and postherpetic neuralgia, Approved December 2004

Drugs Approved in 2003

Cialis (tadalafil); Eli Lilly; Oral agent for the treatment for erectile dysfunction, Approved December 2003

Levitra (vardenafil); Bayer, GlaxoSmithKline; For the treatment of erectile dysfunction related to sexual activity in men, Approved September 2003

Namenda (memantine HCl); Forest Laboratories; For the treatment of moderate to severe dementia of the Alzheimer’s type., Approved October 2003

Drugs Approved in 2002

Avinza (morphine sulfate); Elan Pharmaceuticals; Extended release capsule for the relief of pain requiring continuous, around-the-clock therapy, Approved March 2002

Neurontin (gabapentin); Pfizer; Oral treatment for the management of post-herpetic neuralgia (PHN), Approved May 2002

Rebif (interferon beta-1a); Serono Laboratories; Subcutaneous injection for the treatment of relapsing forms of multiple sclerosis, Approved March 2002

Relpax (eletriptan hydrobromide); Pfizer; For the acute treatment of migraine headaches, Approved December 2002

Strattera (atomoxetine HCl); Eli Lilly; For the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children, adolescents and adults., December 2002

Xyrem (sodium oxybate); Orphan Medical; For the treatment of cataplexy, a sudden loss of muscle tone, associated with narcolepsy, Approved July 2002

Drugs Approved in 2001

Axert (almotriptan malate) tablets; Pharmacia & Upjohn; For the treatment of migraine attacks, Approved May 2001

Bayer Extra Strength Asprin; Bayer; Oral treatment for mild to moderate migraine pain, Approved October 2001

Focalin (dexmethylphenidate HCl); Celgene; For the treatment of attention deficit hyperactivity disorder (ADHD), Approved November 2001

Frova (frovatriptan succinate); Elan Pharmaceuticals; Tablets for the acute treatment of migraine attacks, Approved November 2001

Metadate CD; Celltech Pharmaceuticals; Oral capsules for the treatment of attention deficit hyperactivity disorder, Approved April 2001

Reminyl (galantamine hydrobromide); Janssen Pharmaceuticals; For the treatment of mild to moderate dementia of the Alzheimer's type, Approved February 2001

Ultracet (acetaminophen and tramadol HCl); Ortho-McNeil Pharmaceutical; For the short-term management of acute pain, Approved August 2001

Zomig (zolmitriptan); AstraZeneca; Orally disintegrating tablet for the treatment of acute migraine in adults, Approved February 2001

Drugs Approved in 2000

Depakote ER (divalproex sodium); Abbott Laboratories; For the prophylaxis (prevention) of migraine headaches in adults, Approved August 2000

Exelon (rivastigmine tartrate); Novartis; Indicated for the treatment of mild to moderate dementia of the Alzheimer's type, Approved April 2000

Myobloc; Elan Pharmaceuticals; Injectable solution for the treatment of abnormal head position and neck pain associated with cervical dystonia, Approved December 2000

Neurontin (gabapentin) oral solution; Parke-Davis; For the treatment of partial seizures in pediatric patients three years of age and older, Approved October 2000

Neurontin (gabapentin) oral solution; Parke-Davis; Treatment of partial seizures in adults with epilepsy, Approved March 2000

Novantrone (mitoxantrone hydrochloride); Immunex; For reducing neurologic disability and/or the frequency of clinical relapses in patients with multiple sclerosis, Approved October 2000

Trileptal (oxcarbazepine) Tablets; Novartis; Approved for use as adjunctive therapy in the treatment of partial seizures in children (monotherapy for adults), Approved January 2000

Zonegran (zonisamide) Capsules; Dainippon Pharmaceutical; Adjunctive therapy for treatment of partial seizures in adults with epilepsy, Approved March 2000

Drugs Approved in 1999

Aggrenox; Boehringer Ingelheim; Aggrenox (aspirin/extended-release dipyridamole) 25mg/200mg capules for the prevention of recurrence of stroke, Approved November 1999

Cenestin; Duramed Pharmaceuticals; Treatment for symptoms associated with menopause, Approved July 1999

Comtan; Novartis; 200mg entacapone tablets, October 19, 1999

Keppra; UCB; Levetiracetam tablets for adjunctive treatment of partial onset seizures in adults with epilepsy, Approved November 1999

Lamictal (lamotrigine) Chewable Dispersible Tablets; GlaxoSmithKline; Treatment for epileptic seizures, Approved June 1999

Lidoderm Patch (lidocaine patch 5% ); Hind Health Care; Treatment of pain in post-herpetic neuralgia, Approved June 1999

Sonata; American Home Products; Treatment fo insomnia, Approved August 1999

Topamax (topiramate); Ortho-McNeil Pharmaceutical; Treatment for epilepsy in pediatric patients, Approved July 1999

Drugs Approved in 1998

Amerge; GlaxoSmithKline; Treatment for acute migraine, Approved February 1998

Clonazepam; Watson Pharmaceuticals; Generic equivalent of Klonopin, Approved January 1998

Cylert; Abbott Laboratories; Treatment for Attention Deficit Disorder, Approved October 1998

Excedrin Migraine; Bristol-Myers Squibb; Treatment for mild to moderate migraine pain, Approved January 1998

Lamictal Chewable Dispersible Tablets; GlaxoSmithKline; Treatment for Epilepsy, Approved August 1998

Maxalt; Merck; Acute treatment of migraine headache, Approved June 1998

Naltrexone Hydrochloride Tablets; Barr Laboratories; Generic equivalent of Revia, Approved May 1998

Oxycodone and Aspirin; Watson Pharmaceuticals; Generic equivalent of Percodan, Approved March 1998

Tasmar; Roche; Treatment for Parkinson's Disease, Approved January 1998

Drugs Approved in 1997

Bromfenac; Duract, Wyeth-Ayerst Laboratories; Management of acute pain, Approved July 1997

Carbatrol; Elan Pharmaceuticals; Treatment for epileptic seizures and trigeminal neuralgia, Approved September 1997

Copaxone; Teva Pharmaceutical; Treatment for relapsing-remitting multiple sclerosis, Approved January 1997

Galzin (zinc acetate); Teva Pharmaceutical; Treatment for Wilson’s disease, Approved January 1997

Imitrex (sumatriptan) injection and tablets; GlaxoSmithKline; Treatment for migraine headaches, Approved August 1997

Imitrex (sumatriptan) nasal spray; GlaxoSmithKline; Treatment for migraine, Approved November 1997

Migranal; Novartis; Treatment for migraine headaches, Approved December 1997

Mirapex; Pharmacia & Upjohn, Boehringer Ingelheim; Treatment for Parkinson’s Disease, Approved June 1997

NORCO tablets (Hydrocodone Bitartrate/Acetaminophen 10 mg/325 mg); Watson Pharmaceuticals; Treatment for moderate to moderately severe pain, Approved February 1997

Oxycodone with Acetaminophen 5mg/325mg; Watson Pharmaceuticals; Generic equivalent of Percocet and Tylox, Approved November 1997

Pramipexole; Pharmacia & Upjohn; Treatment for Parkinson's Disease, Approved July 1997

Quadramet (Samarium Sm 153 Lexidronam Injection); DuPont Merck Pharmaceutical Company; Treatment for pain associated with bone cancer, Approved March 1997

Requip (ropinirole hydrochloride); SmithKline Beecham; Treatment for Parkinson's Disease, Approved September 1997

Selegiline tablets; Teva Pharmaceutical; Generic equivalent of Eldepryl tablets, Approved January 1997

Topamax (topiramate); Ortho-McNeil Pharmaceutical; Treatment for partial onset seizures, Approved January 1997

VERSED (midazolam HCI); Roche; Treatment for sedating children who must undergo painful surgery, Approved March 1997

Zomig (zolmitriptan); AstraZeneca; Treatment for migraine, Approved November 1997

Drugs Approved in 1996

Anexsia; Mallinckrodt Group; Treatment for chronic pain, Approved August 1996

ARICEPT (donepezil hydrochloride); Eisai; Treatment for Alzheimer's Disease, Approved December 1996

Depakote (divalproex sodium); Abbott Laboratories; Treatment for epilepsy, Approved June 1996

Depakote (divalproex sodium); Abbott Laboratories; Treatment for migraine headaches, Approved March 1996

Iontocaine; Iomed; Needle-free anesthetic, Approved May 1996

Kadian; Purepac Pharmaceutical; Treatment for chronic moderate to severe pain, Approved July 1996

Merrem I.V. (meropenem); AstraZeneca; Treatment for intra-abdominal infections and bacterial meningitis, Approved June 1996

Redux (dexfenfluramine hydrochloride); Wyeth; Treatment for obesity, Approved May 1996

Tegretol (carbamazepine); Ciba Pharmaceuticals; Treatment for young children with epilepsy, Approved March 1996

Tegretol XR (carbamazepine); Ciba-Geigy; Anti-epileptic treatment, Approved May 1996

UltraJect; Mallinckrodt Group; Treatment for chronic pain, Approved August 1996

Visipaque (iodixanol); Nycomed; Diagnostic contrast agent, Approved April 1996

Zanaflex (tizanidine hydrochloride); Elan Pharmaceuticals; Treatment for muscle spasticity, Approved December 1996

Drugs Approved in 1995

Avonex (Interferon Beta 1-A); Biogen IDEC; Treatment for multiple sclerosis, Recommended for Approval in December 1995

Rilutek (riluzole); Rhone Poulenc Rorer; Treatment for amyotrophic lateral sclerosis (ALS), Approved December 1995