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Lixivaptan Approval Status

FDA Approved: No
Generic name: lixivaptan
Company: Chiesi USA, Inc.
Treatment for: Hyponatremia

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 Status and FDA Approval Process for lixivaptan

DateArticle
Nov  1, 2012Cornerstone Therapeutics Receives Complete Response Letter From the FDA for Lixivaptan
Sep 13, 2012Cornerstone Therapeutics Provides Update on FDA Advisory Committee Discussion of Lixivaptan

Further information

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