Regulation - Otsuka, Pharmaceutical


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FDA accepts NDA filing for Lundbeck and Otsuka's brexpiprazole

FDA accepts NDA filing for Lundbeck and Otsuka's brexpiprazole


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


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


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


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


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


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


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


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

Asia-PacificNephrology and HepatologyOtsukaPharmaceuticalRegulationSamscatolvaptan

Setback for Otsuka's tolvaptan


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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

AbilifyAnti-Arthritics/RheumaticsArcalystBristol-Myers SquibbLegalNeurologicalNorth AmericaOtsukaPatentsPharmaceuticalRegeneronRegulation

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