Cornerstone’s Hyponatremia Therapy Lixivaptan Will Get Advisory Panel Scrutiny
This article was originally published in The Pink Sheet Daily
Executive Summary
The hyponatremia drug is a selective vasopressin V2-receptor antagonist, like Astellas’ Vaprisol and Otsuka’s Samsca.
You may also be interested in...
FDA Review Panel For Cornerstone’s Lixivaptan To Consider Safety Of Outpatient Initiation
The Cardiovascular and Renal Drugs Advisory Committee will face a choice between an agency reviewer’s cautious approach to titration and the sponsor’s push for easier access to the hyponatremia drug.
FDA Enforcement To Be More "Swift, Aggressive" As Centers Share Techniques
FDA's ramped up enforcement efforts will include a much more collaborative approach between the agency's centers, staffers told the Food and Drug Law Institute meeting on enforcement in Washington Oct. 13
FDA Panel Blesses Otsuka’s Hyponatremia Drug
Oral therapy jumps efficacy-but-no-clinical-benefit hurdle.