| 2018-04-25 |
Otsuka Pharmaceutical Development & Commercialization, Inc. |
Otsuka's JYNARQUE™ (tolvaptan) Approved by U.S. FDA as the First Treatment to Slow Kidney Function Decline in Adults at Risk of Rapidly Progressing Autosomal Dominant Polycystic Kidney Disease (ADPKD) otsuka.co.jp ↗ |
| 2018-04-24 |
Otsuka Pharmaceutical Development & Commercialization, Inc. |
Otsuka’s JYNARQUE™ (tolvaptan) Approved by U.S. FDA as the First Treatment to Slow Kidney Function Decline in Adults at Risk of Rapidly Progressing Autosomal Dominant Polycystic Kidney Disease (ADPKD) otsuka-us.com ↗ |
| 2017-11-09 |
Otsuka Pharmaceutical Development & Commercialization, Inc. |
U.S. FDA Accepts Otsuka's Resubmission to Support a Regulatory Review of Tolvaptan in the Treatment of ADPKD otsuka.co.jp ↗ |
| 2017-11-08 |
Otsuka Pharmaceutical Development & Commercialization, Inc. |
FDA Accepts Otsuka’s Resubmission To Support A Regulatory Review Of Tolvaptan In The Treatment Of ADPKD otsuka-us.com ↗ |
| 2017-11-05 |
Otsuka Pharmaceutical Development & Commercialization, Inc. |
Otsuka Announces Phase 3 Results for Tolvaptan in Patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) otsuka.co.jp ↗ |
| 2017-11-04 |
Otsuka Pharmaceutical Development & Commercialization, Inc. |
Otsuka Announces Phase 3 Results for Tolvaptan in Patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) otsuka-us.com ↗ |
| 2017-10-27 |
Otsuka Pharmaceutical Development & Commercialization, Inc. |
Otsuka To Host Web Briefing on Tolvaptan Phase 3 Trial Results In Polycystic Kidney Disease otsuka-us.com ↗ |
| 2017-05-22 |
Otsuka Pharmaceutical Development & Commercialization, Inc. |
Otsuka Announces Results of Phase 3 Data on Tolvaptan Under Development for ADPKD in U.S. otsuka.co.jp ↗ |
| 2017-05-21 |
Otsuka Pharmaceutical Development & Commercialization, Inc. |
Otsuka Announces Results of Phase 3 Data on Tolvaptan Under Development for ADPKD in U.S. otsuka-us.com ↗ |
| 2015-02-27 |
Otsuka Pharmaceutical Development & Commercialization, Inc. |
CHMP Recommends JINARC (Tolvaptan) for Approval in EU: The First Pharmaceutical Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD)® otsuka.co.jp ↗ |
| 2014-06-11 |
Otsuka Pharmaceutical Development & Commercialization, Inc. |
Otsuka Pharmaceutical Initiates Phase 3 Clinical Trial of Tolvaptan in Patients with Autosomal Dominant Polycystic Kidney Disease otsuka-us.com ↗ |
| 2013-12-27 |
Otsuka Pharmaceutical Development & Commercialization, Inc. |
European Medicines Agency (EMA) Accepts Otsuka's Marketing Authorisation Application (MAA) for Tolvaptan, an Investigational Compound for Autosomal Dominant Polycystic Kidney Disease (ADPKD) otsuka.co.jp ↗ |
| 2013-08-30 |
Otsuka Pharmaceutical Development & Commercialization, Inc. |
Otsuka Receives Complete Response Letter From U.S. Food And Drug Administration For Tolvaptan For Use In Patients With Autosomal Dominant Polycystic Kidney Disease otsuka.co.jp ↗ |
| 2013-08-06 |
Otsuka Pharmaceutical Development & Commercialization, Inc. |
U.S. Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee Recommends Against Approval of Otsuka Pharmaceutical's Tolvaptan for Use in Autosomal Dominant Polycystic Kidney Disease (ADPKD) otsuka.co.jp ↗ |
| 2013-08-05 |
Otsuka Pharmaceutical Development & Commercialization, Inc. |
U.S. Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee Recommends Not to Approve Otsuka Pharmaceutical’s Tolvaptan for Use in Autosomal Dominant Polycystic Kidney Disease (ADPKD) otsuka-us.com ↗ |
| 2013-06-03 |
Otsuka Pharmaceutical Development & Commercialization, Inc. |
Otsuka Pharmaceutical Submits New Drug Application in Japan for Tolvaptan for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD) otsuka.co.jp ↗ |
| 2013-04-12 |
Otsuka Pharmaceutical Development & Commercialization, Inc. |
Otsuka's New Drug Application For Tolvaptan, An Investigational Compound For Autosomal Dominant Polycystic Kidney Disease (ADPKD), Accepted For Review By The US Food And Drug Administration (FDA) otsuka.co.jp ↗ |
| 2012-11-05 |
Otsuka Pharmaceutical Development & Commercialization, Inc. |
Otsuka's Investigational Compound for Autosomal Dominant Polycystic Kidney Disease (ADPKD), Tolvaptan, Meets Primary Endpoint in a Phase III Clinical Trial otsuka.co.jp ↗ |
| 2010-12-10 |
Otsuka Pharmaceutical Development & Commercialization, Inc. |
World's First Aquaretic Agent for the Treatment of Volume Overload in Patients with Heart Failure Samsca Tablets 15mg (tolvaptan), Vasopressin V-Receptor Antagonist, to be Launched in Japan on December 14®2 otsuka.co.jp ↗ |
| 2010-10-27 |
Otsuka Pharmaceutical Development & Commercialization, Inc. |
SAMSCA Tablets 15mg (tolvaptan), Vasopressin V-Receptor Antagonist, Receive Regulatory Approval in Japan™2 otsuka.co.jp ↗ |
| 2009-08-04 |
Otsuka Pharmaceutical Development & Commercialization, Inc. |
The European Commission Approves SAMSCA (tolvaptan), Europe's First and Only Oral Vasopressin Antagonist for Hyponatraemia Secondary to Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) .™ otsuka.co.jp ↗ |
| 2009-05-21 |
Otsuka Pharmaceutical Development & Commercialization, Inc. |
FDA Approves SAMSCA (tolvaptan), The First and Only Oral Vasopressin Antagonist to Treat Patients with Clinically Significant Hypervolemic and Euvolemic Hyponatremia™ otsuka.co.jp ↗ |
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