Lixivaptan FDA Approval Status
Lixivaptan is an investigational selective vasopressin 2 receptor antagonist for the treatment of symptomatic hypervolemic and euvolemic hyponatremia.
In November 2012, Cornerstone Therapeutics Inc. announced the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA), advising the company that the New Drug Application (NDA) for lixivaptan had not been approved.
Development Timeline for lixivaptan
|Nov 1, 2012||Cornerstone Therapeutics Receives Complete Response Letter From the FDA for Lixivaptan|
|Sep 13, 2012||Cornerstone Therapeutics Provides Update on FDA Advisory Committee Discussion of Lixivaptan|
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