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Vaprisol Approval History

FDA Approved: Yes (First approved December 29, 2005)
Brand name: Vaprisol
Generic name: conivaptan hydrochloride
Dosage form: Injection
Company: Astellas Pharma US, Inc.
Treatment for: Hyponatremia

Vaprisol (conivaptan hydrochloride injection) is an arginine vasopressin antagonist for the treatment of euvolemic and hypervolemic hyponatremia in hospitalized patients.

Development History and FDA Approval Process for Vaprisol

DateArticle
Oct 22, 2008Approval FDA Approves Astellas' Vaprisol (Conivaptan Hydrochloride Injection) Premixed in 5% Dextrose for the Treatment of Hyponatremia
Mar  2, 2007Approval FDA Approves Astellas' Vaprisol for the Treatment of Hypervolemic Hyponatremia
Dec 29, 2005Approval Vaprisol Astellas Pharma US, Inc. - Treatment for Euvolemic Hyponatremia
Dec  1, 2004FDA Issues Approvable Letter for Yamanouchi's Investigational Hyponatremia Treatment Conivaptan Hydrochloride Injection
Feb  2, 2004Yamanouchi Pharma America Submits New Drug Application to the FDA for Conivaptan Hydrochloride to treat Hyponatremia

Further information

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