Keep Updated August 2013

Tolvaptan public hearing recording now available

We want to thank all who testified and submitted letters (157!) to the FDA’s Cardiovascular and Renal Drugs Advisory Committee meeting on Aug. 5 to review the new drug application for tolvaptan. While the Committee voted 9 to 6 against […]

PKD Foundation |

FDA responds to tolvaptan new drug application

Otsuka Pharmaceutical Development & Commercialization, Inc. announced that they received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the new drug application for tolvaptan to treat adult patients with ADPKD. The FDA issues CRLs […]

PKD Foundation |

FDA advisory committee completes review of tolvaptan

The U.S. Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee met on Aug. 5, 2013, to hear presentations from researchers, clinicians and the public. Several people associated with the PKD Foundation spoke about the burden of PKD, […]

PKD Foundation |