Boehringer Ingelheim Pharmaceuticals Inc. / D. / H. US Medical Director Boehringer Ingelheim Pharmaceuticals Inc. / Pharmaceuticals Inc. / /
Facility
McMaster University / /
IndustryTerm
prevention of stroke / /
MedicalCondition
atrial fibrillation / stroke / /
Organization
office of Drug Evaluation / McMaster University / Center for Drug Evaluation and Research / FOOD AND DRUG ADMINISTRATION / Renal Drug Products / Cardiovascular And Renal Drugs Advisory Committee / /
Person
A. Michael Lincoff / Anuja Patel / Need Professor Stuart Connolly / Review Nhi Beasley / Pharmacometrics Reviewer / Opening Remarks Norman Stockbridge / Paul Reilly / Stuart Connolly / Efficacy Review Aliza Thompson / Christopher D. Corsico / Salim Yusuf / /
Position
Director / Division of Cardiovascular / Committee Acting Chair / CRDAC Introduction / Acting Designated Federal Official / Acting Chair of Committee / Professor / Clinical Team Leader Division of Cardiovascular and Renal Products Safety Review Nhi Beasley / Clinical Team Leader Division of Cardiovascular and Renal Products Safety / /
The committees will discuss new drug application (NDA[removed], sodium oxybate, 375 milligrams per milliliter (mg/ml) oral solution, sponsored by Jazz Pharmaceuticals, with a proposed indication for the treatment of fibro