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FDA Approved Drugs » Therapeutic Areas

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FDA Approved Drugs by Therapeutic Area

Search by therapeutic area for drugs approved by the Food and Drug Administration (FDA) for sale in the United States. Click on an area below to view the complete list of drugs in that category or review descriptions for our therapeutic area list to assist you in your search.

Find out more about the types of drugs included in this listing.

FDA Approved Drugs for Neurology

Drugs Approved in 2014

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

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

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

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