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FDA accepts NDA filing for Lundbeck and Otsuka's brexpiprazole

FDA accepts NDA filing for Lundbeck and Otsuka's brexpiprazole

24-09-2014

The US Food and Drug Administration has accepted the filing for review of brexiprazole for the treatment…

CNS DiseasesLundbeckOtsukaPharmaceuticalRegulationUSA

Lundbeck and Otsuka file for US approval of brexpiprazole

Lundbeck and Otsuka file for US approval of brexpiprazole

14-07-2014

Danish CNS drug specialist Lundbeck and Japanese drugmaker Otsuka have submitted a New Drug Application…

brexpiprazoleLundbeckMarkets & MarketingNeurologicalOtsukaPharmaceuticalPiperidinesRegulationUSA

US FDA accepts for review Otsuka and Lundbeck’s sNDA for Abilify Maintena

US FDA accepts for review Otsuka and Lundbeck’s sNDA for Abilify Maintena

30-04-2014

Danish CNS specialist Lundbeck and the US subsidiary of Japan’s Otsuka Pharmaceutical revealed that…

Abilify MaintenaLundbeckNeurologicalOtsukaPharmaceuticalRegulationUSA

Otsuka wins EU approval for Deltyba in MDR-TB

30-04-2014

Japanese drugmaker Otsuka Pharmaceutical says that the European Commission has granted a marketing authorization…

Antibiotics and Infectious diseasesDeltybaEuropeOtsukaPharmaceuticalRegulation

Otsuka’s Samsca, first ADPKD therapy, approved in Japan

25-03-2014

Japanese drugmaker Otsuka Pharmaceutical says it has become the first company in the world to obtain…

Asia-PacificJapanNephrology and HepatologyOtsukaPharmaceuticalRegulationSamsca

Japanese approval for Forxiga and Lonsurf

24-03-2014

Anglo-Swedish drug major AstraZeneca says that Japanese Ministry of Health, Labor and Welfare approved…

Asia-PacificAstraZenecaDiabetesForxigaJapanLonsurfOncologyOno PharmaceuticalOtsukaPharmaceuticalRegulationTaiho Pharmaceutical

Otsuka and Lundbeck’s schizophrenia drug Abilify Maintena approved in EU

Otsuka and Lundbeck’s schizophrenia drug Abilify Maintena approved in EU

21-11-2013

Japan’s Otsuka Pharmaceutical (TYO: 4768) and partner Lundbeck (LUN: CO) have received approval from…

Abilify MaintenaAsia-PacificEuropeLundbeckNeurologicalOtsukaPharmaceuticalRegulation

Otsuka's Samsca gains additional indication in Japan

17-09-2013

Japanese drugmaker Otsuka (TYO: 4768) says that its vasopressin V2 receptor antagonist Samsca (tolvaptan)…

Asia-PacificNephrology and HepatologyOtsukaPharmaceuticalRegulationSamscatolvaptan

Setback for Otsuka's tolvaptan

30-08-2013

The US subsidiary of Japanese drugmaker Otsuka Pharmaceutical (TYO: 4768) has received a Complete Response…

Nephrology and HepatologyOtsukaPharmaceuticalRegulationRest of the Worldtolvaptan

Negative advisory view for Otsuka's tolvaptan in ADPKD

06-08-2013

Japanese drugmaker Otsuka Pharmaceutical (TYO: 4768) says that the US Food and Drug Administration's…

Nephrology and HepatologyNorth AmericaOtsukaPharmaceuticalRegulationtolvaptin

UK's NICE plans to recommend Abilify for children with bipolar disorder

10-06-2013

UK drugs watch dog the National Institute for Health and Care Excellence (NICE) has issued new draft…

AbilifyEuropeLundbeckNeurologicalOtsukaPharmaceuticalPricingRegulation

US FDA accepts NDAs for Otsuka's tolvaptan and BTG's Varisolve

12-04-2013

Japanese mid-sized drugmaker Otsuka Pharmaceutical (TYO: 4578) says that the US Food and Drug Administration…

BTGCardio-vascularNephrology and HepatologyNorth AmericaOtsukaPharmaceuticalRare diseasesRegulationtolvaptanVarisolve

EMA recommends restricting use of cilostazol-containing medicines

22-03-2013

The European Medicines Agency's Committee on Medicinal Products for Human Use (CHMP) has recommended…

Cardio-vascularcilostazolEkistolEuropeOtsukaPharmaceuticalPletalRegulation

FDA approves Otsuka and Lundbeck's once-monthly Abilify Maintena for schizophrenia

01-03-2013

Japanese drugmaker Otsuka Pharmaceutical (TYO: 4578) and Danish partner Lundbeck (LUND: DC) have received…

Abilify MaintenaAlkermesLundbeckNeurologicalNorth AmericaOtsukaPharmaceuticalRegulation

Taiho Pharma files for approval of cancer drug TAS-102 in Japan

27-02-2013

Japanese drugmaker Taiho Pharmaceutical, a subsidiary of Otsuka (TYO: 4768) says that it submitted an…

Asia-PacificOncologyOtsukaPharmaceuticalRegulationTaiho PharmaceuticalTAS-102

Japanese approvals for Novo's Ryzodeg, UCB/Otsuka's Neupro and B-MS/Pfizer's Eliquis

27-12-2012

Danish insulin giant Novo Nordisk (NOVN: NV) revealed on December 15 that the Japanese Ministry of Health,…

Asia-PacificBristol-Myers SquibbCardio-vascularDiabetesEliquisNeuproNeurologicalNovo NordiskOtsukaPfizerPharmaceuticalRegulationRyzodegUCB

Resubmission of aripiprazole NDA accepted; AstraZeneca bond issue

12-09-2012

Danish CNS-focused drugmaker Lundbeck (LUND: DC) and Japanese partner Otsuka Pharmaceutical (TYO: 4668)…

aripiprazole depotAstraZenecaFinancialLundbeckNeurologicalNorth AmericaOtsukaPharmaceuticalRegulation

Otsuka files Abilify, first antipsychotic for major depressive disorder in Japan

04-09-2012

Japanese drugmaker Otsuka Pharmaceutical (TYO: 4768) has filed an additional indication for Abilify (aripiprazole)…

AbilifyAsia-PacificNeurologicalOtsukaPharmaceuticalRegulation

Janssen-Cilag files for EU approval of bedaquiline in MDR-TB

02-09-2012

Johnson & Johnson (NYSE: JNJ) Belgium-based subsidiary Janssen-Cilag International submitted a Marketing…

Antibiotics and Infectious diseasesbedaquilinedelamanidEuropeJanssen-CilagJohnson & JohnsonOtsukaPharmaceuticalRegulation

Japanese filings for Shionogi's metreleptin and Otsuka's tolvaptin

06-08-2012

Japanese drugmaker Shionogi (TYO: 4507) said last week that it has filed a New Drug Application with…

Asia-PacificmetreleptinNephrology and HepatologyOtsukaPharmaceuticalRare diseasesRegulationSamscaShionogitolvaptin

USA: FDA panel votes against Regeneron gout drug; Court upholds Abilify patent

09-05-2012

The US Food and Drug Administration's Arthritis Advisory Committee yesterday voted unanimously (11 to…

AbilifyAnti-Arthritics/RheumaticsArcalystBristol-Myers SquibbLegalNeurologicalNorth AmericaOtsukaPatentsPharmaceuticalRegeneronRegulation

Additional indication for Otsuka’s Abilify in Japan

22-01-2012

Japanese drugmaker Otsuka Pharmaceutical (TYO: 4768) said last week that it has received new regulatory…

AbilifyAsia-PacificNeurologicalOtsukaPharmaceuticalRegulation

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