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