Replidyne (RDYN)

[surf1944]

Form 8-K for REPLIDYNE INC

28-Jan-2008

Other Events


Item 8.01. Other Events.

On January 22, 2008, Replidyne, Inc. (the "Company") received a Warning Letter (the "Letter") from the U.S. Food and Drug Administration (the "FDA") pursuant to the completion of the FDA's review of clinical trials performed in connection with the December 2005 new drug application ("NDA") filed by the Company in support of faropenem medoxomil 300 mg tablets twice per day dose, in respect of which the FDA issued a non-approvable letter in October 2006. The clinical trials that supported this NDA were conducted by Bayer Corporation as a previous licensee of faropenem medoxomil. The Company intends to respond timely to the issues raised by the FDA.