Pharmaceuticals
News Releases
News releases related to the central nervous system
2025
Pharmaceuticals
MIREVO®, the first neuropsychological testing program in Japan to support dementia treatment, now available
Pharmaceuticals
Otsuka Announces FDA Plans to Host an Advisory Committee Meeting to Discuss the sNDA for Brexpiprazole in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD)
2024
Pharmaceuticals
JAMA Psychiatry Publishes Results of Otsuka and Lundbeck's Phase 3 Trial of Brexpiprazole in Combination with Sertraline in Treatment of Post-Traumatic Stress Disorder (PTSD) in Adults
Pharmaceuticals
Otsuka and Jolly Good initiate the sale of FACEDUO Dementia Care Support VR
Pharmaceuticals
Otsuka Obtains Exclusive Global Licensing Rights from Ionis to Ulefnersen, a Potential Treatment for Amyotrophic Lateral Sclerosis Caused by Mutations in the Fused in Sarcoma Gene (FUS-ALS)
Pharmaceuticals
Otsuka Obtains Additional Indication for Rexulti®in Japan as an Adjunctive Treatment for Agitation Associated with Dementia due to Alzheimer's Disease
Pharmaceuticals
Otsuka to Participate in the Orange Innovation Project, Promoted by Japan's Ministry of Economy, Trade and Industry
Pharmaceuticals
Otsuka and Jolly Good Launch FACEDUO Dementia Care Support VR
Pharmaceuticals
Otsuka Precision Health and Click Therapeutics Announce Launch of Rejoyn™, the First-And-Only Prescription Digital Therapeutic Cleared by the FDA for the Adjunctive Treatment of Major Depressive Disorder (MDD) Symptoms ーRejoyn, a first-of-its-kind digital treatment designed to help with cognitive control of emotion, is now available in mobile app stores and can be unlocked with a prescription from a healthcare providerー
Pharmaceuticals
Otsuka and Lundbeck Present New REXULTI® (brexpiprazole) Post Hoc Efficacy Data Analyses for Agitation Associated with Dementia Due to Alzheimer's Disease at Alzheimer's Association International Conference (AAIC) 2024
Pharmaceuticals
Otsuka and Lundbeck announce FDA acceptance of sNDA filing for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD)
Pharmaceuticals
Otsuka and Lundbeck Present Results from Three Clinical Trials of Brexpiprazole in Combination with Sertraline for the Treatment of Post-Traumatic Stress Disorder (PTSD) in Adults
Pharmaceuticals
Otsuka to Terminate Development of AVP-786
Pharmaceuticals
Otsuka and Lundbeck submit sNDA for FDA review of brexpiprazole and sertraline combination as potential treatment for PTSD
Pharmaceuticals
FACEDUO Emotion Recognition Training VR now available - Support for those with developmental conditions such as autism spectrum disorder (ASD), which makes it difficult to read emotions -
Pharmaceuticals
U.S. Food and Drug Administration (FDA) Clearance of Rejoyn® First Prescription Digital Therapeutic Authorized in the U.S. for the Adjunctive Treatment of Major Depressive Disorder (MDD) symptoms
Pharmaceuticals
Abilify Maintena® 960mg (aripiprazole) approved in the EU as the first once-every-two-months long-acting injectable for the maintenance treatment of schizophrenia
Pharmaceuticals
Otsuka and Lundbeck Presented New Data Analyses on the Efficacy of REXULTI® (brexpiprazole) for Agitation Associated with Dementia Due to Alzheimer's Disease
Pharmaceuticals
Otsuka and Sumitomo Revise License Agreement - Otsuka holds exclusive rights to develop, manufacture, and commercialize ulotaront and SEP-380135 worldwide -
Pharmaceuticals
Otsuka Announces Phase 3 Topline Results of AVP-786 in the Treatment of Agitation Associated with Dementia due to Alzheimer's Disease
Pharmaceuticals
Otsuka and Jolly Good to Start Delivery of FACEDUO Content for Family Support of People with Severe Social Withdrawal (Hikikomori) FACEDUO is a virtual reality program for social skills training support
2023
Pharmaceuticals
Otsuka Obtains the Additional Indication of Adjunctive Treatment of Major Depressive Disorder for Rexulti® in Japan
Pharmaceuticals
MIREVO®, a New Cognitive Function Testing Application for Dementia Care Support, Obtains Regulatory Approval, a First in Japan
Pharmaceuticals
Otsuka Applies in Japan for the Additional Indication for Agitation Associated with Dementia due to Alzheimer's Disease for Rexulti® (brexpiprazole)
Pharmaceuticals
Otsuka Pharmaceutical Announces Positive Topline Results from Two Pivotal Phase 3 Trials of Centanafadine as a Treatment for Adolescents and Children with Attention-Deficit/Hyperactivity Disorder (ADHD)
Pharmaceuticals
Otsuka Pharmaceutical Enters into Cooperative Agreement with Japan Association of Public Mental Health & Welfare Workers
Pharmaceuticals
Otsuka Pharmaceutical and Lundbeck Announce Topline Results from Two Phase 3 Trials of Brexpiprazole as Combination Therapy with Sertraline for the Treatment of Post-Traumatic Stress Disorder in Adults
Pharmaceuticals
Otsuka Pharmaceutical to Acquire Mindset Pharma - Strengthens pipeline in the area of psychiatric and neurological disorders -
Pharmaceuticals
Sumitomo Pharma and Otsuka Announce Topline Results from Phase 3 DIAMOND 1 and DIAMOND 2 Clinical Studies Evaluating Ulotaront in Schizophrenia
Pharmaceuticals
Otsuka Pharmaceutical announces positive results of phase III trial in Japan showingreduced agitation in patients with Alzheimer's dementia treated with brexpiprazole
Pharmaceuticals
Otsuka and Lundbeck Announce U.S. Food and Drug Administration (FDA) Approval of supplemental New Drug Application (sNDA) for REXULTI® (brexpiprazole) for the Treatment of Agitation Associated with Dementia due to Alzheimer's Disease
Pharmaceuticals
FDA Approves Otsuka and Lundbeck's ABILIFY ASIMTUFII®(aripiprazole), the First, Two-month, Long-acting Injectable (LAI) for the Treatment of Schizophrenia or Maintenance Monotherapy Treatment of Bipolar I Disorder in Adults
Pharmaceuticals
Otsuka and Lundbeck Issue Statement on U.S. Food and Drug Administration (FDA) Advisory Committee Meeting on brexpiprazole for the Treatment of Agitation Associated with Alzheimer's Dementia
Pharmaceuticals
Otsuka Applies for the Additional Indication of Adjunctive Treatmentof Major Depressive Disorder for Rexulti® (brexpiprazole) in Japan
Pharmaceuticals
Otsuka and Schrödinger Announce Single-Target, Drug Discovery Collaboration in Neurology
Pharmaceuticals
Otsuka and Lundbeck announce FDA acceptance and priority review of sNDA for brexpiprazole for the treatment of agitation associated with Alzheimer's dementia
2022
Pharmaceuticals
Otsuka Announces the Launch in Japan of Auto-Injector Dosage Form for AJOVY® Subcutaneous Injection 225mg for Preventive Treatment of Migraine
Pharmaceuticals
Avanir Pharmaceuticals, Inc. Business Will Be IntegratedInto Otsuka America Pharmaceuticals, Inc. as of January 1, 2023
Pharmaceuticals
Otsuka and Jolly Good to Launch FACEDUO, a Virtual Reality Support Program forPatients with Schizophrenia and Their Supporters
Pharmaceuticals
Otsuka and Lundbeck Announce U.S. FDA Acceptance of New Drug Application forAripiprazole 2-month, Ready-to-Use, Long-acting Injectable to Treat Schizophrenia andBipolar I Disorder in Adults
Pharmaceuticals
Otsuka Pharmaceutical announces positive results of phase III trial in Japan for brexpiprazole in the treatment of major depressive disorder
Pharmaceuticals
Otsuka Pharmaceutical and Lundbeck present positive results showing reduced agitation in patients with Alzheimer's dementia treated with brexpiprazole at the 2022 Alzheimer's Association International Conference
Pharmaceuticals
Otsuka Pharmaceutical and Lundbeck announce positive results showing reduced agitation in patients with Alzheimer's dementia treated with brexpiprazole
Pharmaceuticals
European Medicines Agency Commences Review of Aripiprazole2-Month Long-Acting Injectable for the Maintenance Treatment of Schizophrenia in Adult Patients Stabilised with Aripiprazole
Pharmaceuticals
Otsuka Obtains Approval in Japan for Auto-Injector Dosage Form for AJOVY® Subcutaneous Injection 225 mg for Preventive Treatment of Migraine
Pharmaceuticals
Otsuka and Ai-BrainScience Announce Sales Collaboration Agreement for New Cognitive Function Testing Application That Uses Eye Tracking Technology
Pharmaceuticals
Otsuka Enters Agreement with Jolly Good for Co-Development and Sales Rights in Japanfor a Social Skills Training Platform Using Virtual Reality in the Psychiatric Field
Pharmaceuticals
Otsuka and Lundbeck Announce U.S. FDA Approval of Supplemental New Drug Application for REXULTI® (brexpiprazole) to Treat Schizophrenia in Pediatric Patients
2021
Pharmaceuticals
Sumitomo Dainippon Pharma and Otsuka Announce a Worldwide Collaborationand License Agreement for Four Psychiatry and Neurology Compounds
Pharmaceuticals
Otsuka to Launch AJOVY® Subcutaneous Injection 225 mg Syringe in Japan
Pharmaceuticals
Otsuka Obtains Approval in Japan for Orally-Disintegrating-Dose Form of REXULTI® Tablets
Pharmaceuticals
Otsuka reports topline outcomes on a phase II trial that evaluated brexpiprazole for the treatment of borderline personality disorder
Pharmaceuticals
Otsuka Files Application in Japan for Approval of Auto-Injector Dosage Form for AJOVY® Subcutaneous Injection 225 mg for Preventive Treatment of Migraine
Pharmaceuticals
AJOVY® Subcutaneous Injection 225 mg Syringe, as a Preventive Treatment of Migraine, Granted Approval in Japan
Pharmaceuticals
Otsuka and Lundbeck announce decision to continue phase III clinical trial evaluating brexpiprazole for treatment of agitation in patients with Alzheimer's-type dementia
Pharmaceuticals
Otsuka and Perception Neuroscience Announce Collaboration on Development of PCN-101 (R-ketamine) in Japan for Treatment of Depressive Disorders
2020
Pharmaceuticals
Otsuka's ABILIFY MAINTENA approved for the additional indication of bipolar I disorder in Japan
Pharmaceuticals
Otsuka Filed Application in Japan for Approval of Fremanezumab as a Prophylactic Treatment for Migraine
Pharmaceuticals
Otsuka Pharmaceutical and Axcelead Drug Discovery Partners announce joint research in CNS indications
Pharmaceuticals
Otsuka Announces Positive Top-line Results from Two Phase 3 Studies of Centanafadine for the Treatment of Attention-deficit Hyperactivity Disorder (ADHD) in Adult Patients
Pharmaceuticals
Otsuka announces positive top-line results from clinical trials in Japan offremanezumab as a prophylactic treatment for migraine
2019
Pharmaceuticals
Otsuka Pharmaceutical and Avanir Pharmaceuticals to Continue Clinical Development ofInvestigational AVP-786 for the Treatment of Agitation in Patients with Alzheimer's Dementia
Pharmaceuticals
Otsuka's Subsidiary Avanir Pharmaceuticals Reports Top-line Data from Second Phase 3 Trial Evaluating Investigational AVP-786 for the Treatment of Moderate-to-Severe Agitation in Patients with Alzheimer's Dementia
Pharmaceuticals
Otsuka Applies for the Additional Indication in Japan of Bipolar Disorder for ABILIFY MAINTENA for Suspended Release Injectable Suspension
Pharmaceuticals
Otsuka's Subsidiary Avanir Pharmaceuticals Reports Phase 3 Data Evaluating Investigational AVP-786 for the Treatment of Moderate-to-Severe Agitation in Patients with Alzheimer's Dementia
Pharmaceuticals
Notice regarding the conclusion of co-development/co-promotion activities in Japan for the anti-epileptic drug "E Keppra"
Pharmaceuticals
Selincro Tablets 10mg Launched in Japan
Pharmaceuticals
Otsuka and Lundbeck report phase III data evaluating brexpiprazole for the treatment of manic episodes associated with bipolar I disorder
Pharmaceuticals
Avanir Pharmaceuticals, Inc. Reaches Agreement in Principle with U.S. Department of Justice Regarding NUEDEXTA (dextromethorphan HBr and quinidine sulfate) 20 mg/10 mg capsule
Pharmaceuticals
Selincro (nalmefene) Tablets 10mg Receives Regulatory Approval in Japan
Pharmaceuticals
Otsuka and Click Therapeutics Collaborate to Develop and Commercialize Digital Therapeutics for Patients with Major Depressive Disorder
2018
Pharmaceuticals
Otsuka subsidiary Avanir and Optinose agree to terminate license agreement for migraine treatment ONZETRA®Xsail®
Pharmaceuticals
Otsuka and Lundbeck report positive phase II data for the combination treatment of brexpiprazole and sertraline for the treatment of Post-Traumatic Stress Disorder (PTSD)
Pharmaceuticals
Otsuka and Proteus Digital Health Announce Expanded Collaboration Agreement to Advanced Digital Medicines for Mental Health
Pharmaceuticals
Otsuka and Lundbeck's Rxulti® (brexpiprazole) approved by the European Commission
Pharmaceuticals
Otsuka and Lundbeck's Rxulti® (brexpiprazole) receives positive opinion in EUfrom CHMP for the treatment of schizophrenia in adults
Pharmaceuticals
Otsuka and Lundbeck to Start Third Phase 3 Trial in June to Evaluate Brexpiprazole in the Treatment of Agitation in Patients with Alzheimer's Disease
Pharmaceuticals
REXULTI® Tablets, a New Antipsychotic Drug, Launched in Japan
Pharmaceuticals
Otsuka Receives Approval in Japan for the Manufacture and Sale of New Antipsychotic Drug Rexulti® Tablets for Schizophrenia
2017
Pharmaceuticals
Otsuka and Proteus Announce the First U.S. FDA Approval of a Digital Medicine System: ABILIFY MYCITE® (aripiprazole tablets with sensor)
Pharmaceuticals
Otsuka and Lundbeck will Initiate a Third Phase 3 Trial to Evaluate Brexpiprazole in the Treatment of Agitation in Patients with Dementia of the Alzheimer's Type
Pharmaceuticals
Otsuka Submits a Japan NDA for Nalmefene, a Drug to Reduce Alcohol Consumption in Alcohol-Dependent Patients
Pharmaceuticals
Otsuka and Lundbeck Announce Initiation of Two Phase 3 Trials of Brexpiprazole in Patients with Bipolar I Disorder
Pharmaceuticals
ABILIFY MAINTENA® (aripiprazole) for Extended-Release Injectable Suspension Approved by U.S. FDA for Maintenance Monotherapy Treatment of Bipolar I Disorder
Pharmaceuticals
Otsuka Submits New Drug Application in Japan for Aripiprazole Sertraline Combination Tablets
Pharmaceuticals
Nalmefene, a Drug Candidate to Reduce Alcohol Consumption, Shows Positive Results from Phase III Trial in Japan
Pharmaceuticals
Otsuka and Proteus Digital Heath Resubmit Application to US FDA for First Digital Medicine
Pharmaceuticals
Otsuka and Teva Sign Licensing Agreement for Japan on Prophylactic Migraine Drug Candidate Fremanezumab (TEV-48125)
Pharmaceuticals
Otsuka and Lundbeck Announce Results of Brexpiprazole on Symptoms of Agitation Related to Alzheimer's-type Dementia
Pharmaceuticals
Lundbeck and Otsuka's Brexpiprazole for Adult Patients with Schizophrenia Accepted for Review by EMA
Pharmaceuticals
Otsuka Pharmaceutical to Acquire Neurovance, Inc. Acquisition of clinical-stage company in ADHD widens Otsuka's presence in mental health
Pharmaceuticals
Health Canada Approves Otsuka and Lundbeck's REXULTI (brexpiprazole) as a Treatment for Schizophrenia in Adults
Pharmaceuticals
Otsuka Submits New Drug Application in Japan for Brexpiprazole in the Treatment of Schizophrenia
2016
Pharmaceuticals
FDA Accepts For Review A Supplemental New Drug Application To Expand Labeling Of Abilify Maintena® (aripiprazole) For The Treatment Of Bipolar I Disorder
Pharmaceuticals
New 1 mg Tablet Dosage of Antipsychotic ABILIFY Available in Japan
Pharmaceuticals
Antipsychotic ABILIFY Gains Approval in Japan for the Additional Indication of Irritability Associated with Pediatric Autism Spectrum Disorder
Pharmaceuticals
U.S. FDA Approves Labeling Update of REXULTI®(brexpiprazole) for Maintenance Treatment of Schizophrenia in Patients in the U.S.
Pharmaceuticals
Headline conclusions from the phase III study of idalopirdine (Lu AE58054) for cognitive symptoms associated with Alzheimer's disease
Pharmaceuticals
"Neupro® Patch", a Dopaminergic, Anti-Parkinsonian Drug,Will Become Available in Japan in an Additional New Dosage, "Neupro Patch 18 mg"
Pharmaceuticals
FDA Issues Complete Response Letter For Digital Medicine New Drug Application
Pharmaceuticals
ABILIFY for Extended Release Injectable Suspension, Used to treat Schizophrenia, Has Received Approval in Japan for Administration at Deltoid Muscle Site
Pharmaceuticals
Anti-epileptic Drug E Keppra® (generic name: levetiracetam) Obtains Additional Indication of Adjunctive Therapy for Generalized Tonic-Clonic Seizures in Japan
Pharmaceuticals
Otsuka's Subsidiary Avanir Pharmaceuticals Announces U.S. FDA Approval of ONZETRA™Xsail™ for the Acute Treatment of Migraine in Adults
2015
Pharmaceuticals
Otsuka Files for Approval in Japan for an Additional Indication for the Antipsychotic ABILIFY: Excitability Associated with Juvenile Autism
Pharmaceuticals
E Keppra® Injectable, to be Launched in Japan on December 1; Will Contribute to Uninterrupted Treatment of Epilepsy Patients Aged 4 and Over with Partial-onset Seizures
Pharmaceuticals
Otsuka Pharmaceutical Affiliate Avanir Pharmaceuticals Announces Initiation of Phase III Trial of AVP-786 for Agitation in Patients with Alzheimer's Disease
Pharmaceuticals
U.S. FDA Accepts First Digital Medicine New Drug Application for Otsuka and Proteus Digital Health
Pharmaceuticals
Otsuka Pharmaceutical's Subsidiary Avanir Pharmaceuticals Prevails in NUEDEXTA® Patent Appeal Maintaining Exclusivity Through 2026 in the U.S.
Pharmaceuticals
U.S. FDA Approves Otsuka and Lundbeck's REXULTI® (brexpiprazole) as Adjunctive Treatment for Adults with Major Depressive Disorder and as a Treatment for Adults with Schizophrenia
Pharmaceuticals
New Treatment Option in Japan for People Living With Schizophrenia - Abilify for Extended-release Injectable Suspension, for Intramuscular Use, Launched on May 25
Pharmaceuticals
Results of Phase III Study of Brexpiprazole in Adult Patients with Schizophrenia Published in American Journal of Psychiatry
Pharmaceuticals
Otsuka Granted Approval in Japan for a New Formulation of ABIILIFY - ABILIFY for Extended-release Injectable Suspension, for Intramuscular Use - Indicated for Schizophrenia
Pharmaceuticals
Novel Anti-epileptic Drug E Keppra® Filed in Japan for Additional Indication of Adjunctive Therapy for Generalized Tonic-clonic Seizures
Pharmaceuticals
Novel Anti-epileptic Drug E Keppra® Approved in Japan for Additional Indication as Monotherapy for Partial-onset Seizures, in Addition to Existing Indication as Adjunctive Therapy for These Seizures
2014
Pharmaceuticals
U.S. FDA Accepts Otsuka and Lundbeck's Filing for Review of Brexpiprazole for the Treatment of Schizophrenia and as Adjunctive Therapy for the Treatment of Major Depression
Pharmaceuticals
E Keppra® 500 mg Injectable For Monotherapy Treatment of Epilepsy Submitted For Regulatory Review in Japan
Pharmaceuticals
Otsuka and Lundbeck Submit New Drug Application in The US for Brexpiprazole for The Treatment of Schizophrenia and as Adjunctive Therapy for The Treatment of Major Depressive Disorder
Pharmaceuticals
E Keppra® Injectable Receives Marketing Authorization in Japan Will Contribute to Uninterrupted Treatment of Epilepsy Patients Aged Four and Over
Pharmaceuticals
Launch in Japan of Samsca 30 mg Tablet Formulation for Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD), an Orphan Disease
Pharmaceuticals
IBM and Otsuka Develop Transformative Care Coordination Solution
Pharmaceuticals
Otsuka Pharmaceutical's Samsca® Approved in Japan as the World's First Drug Therapy for ADPKD, a Rare Kidney Disease
Pharmaceuticals
Anti-Epileptic Drug E Keppra® Filed in Japan for Additional Indication of Monotherapy for Partial-Onset Seizures
Pharmaceuticals
Otsuka's Antipsychotic Aripiprazole Awarded the 60th Okochi Memorial Prize
Pharmaceuticals
Otsuka and Lundbeck Announce Once-Monthly Abilify Maintena™ Approved in Canada for the Maintenance Treatment of Schizophrenia in Stabilized Adult Patients
Pharmaceuticals
Otsuka and Lundbeck to present new data on brexpiprazole in major depressive disorder (MDD) at European Psychiatry Association 2014 Congress
Pharmaceuticals
Otsuka Pharmaceutical Submits Marketing Authorization Application in Japan for Abilify Once-Monthly Injectable Form for the Treatment of Schizophrenia
2013
Pharmaceuticals
European Medicines Agency (EMA) Accepts Otsuka's Marketing Authorisation Application (MAA) for Tolvaptan, an Investigational Compound for Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Pharmaceuticals
Lundbeck and Otsuka to Co-Develop a Vaccine, Lu AF20513, Their Third Collaborative Development Project to Tackle Alzheimer's Disease
Pharmaceuticals
Otsuka and Lundbeck's Once-Monthly Abilify Maintena® (Aripiprazole) Now Approved in Europe for Maintenance Treatment of Schizophrenia in Adult Patients Stabilized with Oral Aripiprazole
Pharmaceuticals
Lundbeck and Otsuka Initiate Phase III Clinical Trials on Lu AE58054 as a New Add-On Treatment for Alzheimer's Disease
Pharmaceuticals
Otsuka And Lundbeck Receive Postive Chmp Opinion In Europe For Abilify Maintena™, A Once-Monthly Injectable For Schizophrenia
Pharmaceuticals
Phase II clinical data show statistically significant improvement for Lu AE58054 as add-on to donepezil, versus donepezil alone, on cognitive symptoms of Alzheimer's disease*1 Lundbeck and Otsuka present data at Alzheimer’s Association International Conference 2013
Pharmaceuticals
Two New Formulations of E Keppra® Developed Dry Syrup Obtains Approval; Application Filed for Injectable Formulation Address various needs of patients with epilepsy from 4 years of age and contribute to improvement of compliance with medication
Pharmaceuticals
A New Choice of Therapy for the Treatment of Depression:ABILIFY® Granted Additional Approval as Adjunctive Therapy for the Treatment of Depression in Japan
Pharmaceuticals
Antiepileptic Drug E Keppra® Tablet Approved in Japan for Pediatric Epilepsy (Partial-Onset Seizures)
Pharmaceuticals
Study Shows Effects of Treatment with ABILIFY MAINTENA™ (Aripiprazole) on Psychiatric Hospitalization Rates for Patients with Schizophrenia
Pharmaceuticals
Otsuka Pharmaceutical's 44-member Employee Dance Group "Otsuka-Ren" Presented Traditional "Awa-Odori" of Tokushima, Where the Company Originates From, At Copenhagen Sakura Festival Held in Denmark
Pharmaceuticals
"Epi Diary" - An Epilepsy Diary Application for iOS A New Communication Tool for Patients with Epilepsy and their Physicians Now Available at https://itunes.apple.com/app/epi-diary/id616736809?Is=1&mt=8
Pharmaceuticals
Lundbeck and Otsuka Further Expand Alliance and Enter Into Collaboration For the Development and Commercialization of Lu AE58054 In Development For Alzheimer's Disease
Pharmaceuticals
Otsuka Advancing Rapidly in Central Nervous System Disorders; Expanding Its Existing Collaboration with Lundbeck
Pharmaceuticals
FDA Approves Once-Monthly ABILIFY MAINTENA™ (Aripiprazole) For Extended-Release Injectable Suspension for the Treatment of Schizophrenia
Pharmaceuticals
The First Transdermal Dopamin Agonist in Japan Neupro® Patch, For Both Parkinson's Disease and Restless Legs Syndrome, To Be Launched on February 26
Pharmaceuticals
The European Medicines Agency (EMA) Approves Aripiprazole (ABILIFY®) for the Treatment of Moderate to Severe Manic Episodes in Bipolar I Disorder in Adolescents.
2012
Pharmaceuticals
Otsuka and Lundbeck initiate the regulatory process for aripiprazole (once-monthly) depot formulation in Europe
Pharmaceuticals
The World's Only Transdermal Dopamin Agonist, Neupro® Patch, Approved in Japan for Both Parkinson's Disease and Restless Legs Syndrome
Pharmaceuticals
ABILIFY® ,The First Antipsychotic Agent in Japan Applying for Adjunctive Treatment in Major Depressive Disorder
Pharmaceuticals
UCB Japan Files for Indication of Pediatric Epilepsy (Partial Onset Seizures) for E Keppra® Tablet; New Dry Syrup Formulation Filed at the Same Time
Pharmaceuticals
The Federal Circuit Decision Affirming the Validity of the Asserted Claims of Otsuka's Patent to ABILIFY®
Pharmaceuticals
Results from a Phase 3 Study of Once-monthly Aripiprazole Intramuscular (IM) Depot Formulation for the Maintenance Treatment of Schizophrenia Presented at APA Annual Meeting
Pharmaceuticals
New Antipsychotic Agent "ABILIFY® OD Tablets" Pursues Agreeability for Patients, Enables easy Adherence
Pharmaceuticals
Antipsychotic Agent ABILIFY® Receives Regulatory Approvals for Additional Indication "Improvement of Manic Symptoms Associated with Bipolar Disorder" and for New Dosage Form "ABILIFY® OD Tablets"
Pharmaceuticals
Otsuka Pharmaceutical Files New Drug Application for The Dopamine Agonist Transdermal Patch, Rotigotine Patch, in Japan
Pharmaceuticals
Otsuka Pharmaceutical and UCB focus collaboration in the area of Central Nervous System (CNS) disorders
2011
Pharmaceuticals
New Drug Application for Otsuka's Once-monthly Aripiprazole Depot Formulation for Maitenance Treatment of Adult Patients With Schizophrenia Accepted for Review by the U.S. Food and Drug Administration
Pharmaceuticals
OTSUKA PHARMACEUTICAL CO., LTD. AND H. LUNDBECK A/S Sign Historic Agreement to Deliver Innovative Medicines with Focus on Psychiatric Disorders Worldwide
Pharmaceuticals
Otsuka Pharmaceutical Confirmed Clinical Efficacy of Rotigotine Transdermal System for Restless Legs Syndrome in Phase III Clinical Study in Japan
Pharmaceuticals
Otsuka Pharmaceutical confirmed clinical efficacy of rotigotine trandermal system in Phase III clinical study in patients with advanced Parkinson's disease in Japan
Pharmaceuticals
Otsuka Pharmaceutical Co., LTD. Announces Results from a Phase 2 Study of Investigational Product OPC-34712 as Adjunctive Therapy in Adults with Major Depressive Disorder
Pharmaceuticals
ABILIFY® (aripiprazole) Approved for Maintenance Treatment of Bipolar I Disorder as an Adjunct to Either Lithium or Valproate Data from 52-week maintenance trial showed superiority of adjunctive ABILIFY versus adjunctive placebo on primary study endpoint
Pharmaceuticals
Otsuka Pharmaceutical Files for Additional Indication Regulatory Approval in Japan for ABILIFY®, a Treatment for the Manic Symptoms Associated with Bipolar Disorder
2010
Pharmaceuticals
Defendants Appeal From Final Judgment in U.S. Abilify® Patent Litigation
Pharmaceuticals
Otsuka Prevails in U.S. Abilify® Patent Litigation
Pharmaceuticals
OTSUKA ANNOUNCES PHASE 3 ARIPIPRAZOLE INTRAMUSCULAR (IM) DEPOT TRIAL INTERIM ANALYSIS REVEALS EFFICACY CRITERIA MET
Pharmaceuticals
OTSUKA OPENS FIRST OFFICE IN CANADA Important Milestone for Growing North American Pharmaceutical Operations
Pharmaceuticals
Antiepileptic Drug 'E Keppra® Tablet' with New Mechanism of Action Released on September 17
Pharmaceuticals
E Keppra® (levetiracetam) receives regulatory approval in Japan
Pharmaceuticals
GW and Otsuka Agree Three Year Extension to Global Cannabinoid Research Collaboration
2009
Pharmaceuticals
Galenea and Otsuka Announce Second Extension to Schizophrenia Research Collaboration
Pharmaceuticals
U.S. Food and Drug Administration Approves ABILIFY® (aripiprazole) for the Treatment of Irritability Associated with Autistic Disorder in Pediatric Patients (Ages 6 to 17 Years)
Pharmaceuticals
Otsuka and Bristol-Myers Squibb Extend U.S. Agreement for ABILIFY and Establish a Global Oncology Collaboration
Pharmaceuticals
Antipsychotic agent ABILIFY® Oral Solution 0.1% to be Launched on April 10, 2009 in Japan
2008
Pharmaceuticals
Galenea and Otsuka Pharmaceutical Extend & Expand Schizophrenia Research Collaboration
Pharmaceuticals
Otsuka and UCB agreed to co-develop and co-promote Keppra® and Cimzia® in Japan
Pharmaceuticals
The first drug to be approved in Sweden for intermittent claudication: Pletal® is reimbursed
2006
Pharmaceuticals
BRISTOL-MYERS SQUIBB AND OTSUKA PHARMACEUTICAL CO., LTD. ANNOUNCE EXCLUSIVE LICENSING AGREEMENT FOR DIABETES COMPOUND SAXAGLIPTIN IN JAPAN
Pharmaceuticals
Prix Galien awarded to Abilify® (aripiprazole) for medical innovation
Pharmaceuticals
Drug to treat schizophrenia with a new mechanism of action Antipsychotic agent "Abilify®" Available in Japan from June 8
Pharmaceuticals