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Kiacta Approval Status

FDA Approved: No
Brand name: Kiacta
Generic name: eprodisate
Previous Name: Fibrillex
Company: Neurochem
Treatment for: Amyloid A Amyloidosis

Kiacta (eprodisate) is an investigational glycosaminoglycan mimetic intended for use in the treatment of Amyloid A Amyloidosis.

In July 2007, Neurochem announced the receipt of an Approvable Letter from the U.S. Food and Drug Administration (FDA) advising the company that the New Drug Application (NDA) for Kiacta was approvable pending an additional efficacy trial.

Development Status and FDA Approval Process for Kiacta

DateArticle
Mar 13, 2008Neurochem Moves Eprodisate (Kiacta) Drug Development Program Forward for Amyloid A Amyloidosis
Dec  7, 2007Neurochem Announces Eprodisate (Kiacta) Receives Acknowledgement of Complete Response and is Granted Class 2 Review
Jul 18, 2007Neurochem Receives Approvable Letter for Eprodisate (Kiacta) for Treatment of AA Amyloidosis
Apr 11, 2007Neurochem's Eprodisate (Kiacta) PDUFA Date Extended Three Months by FDA
Oct 16, 2006Neurochem submits a complete response to FDA approvable letter for Kiacta
Aug 11, 2006Neurochem Receives Approvable Letter for Eprodisate (Kiacta) for Treatment of AA Amyloidosis
Apr 18, 2006Neurochem Announces Fibrillex NDA Filed and Granted Priority Review
Feb 13, 2006Neurochem Submits NDA for Fibrillex
Aug 22, 2005Neurochem Initiates Submission of NDA for Fibrillex
Jun 30, 2005FDA Agrees to File and Review NDA for Fibrillex

Further information

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