|>>Cardiome Provides Regulatory Update|
Thursday October 9, 12:20 pm ET
VANCOUVER, Oct. 9 /PRNewswire-FirstCall/ - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced that it has been informed by its co-development partner, Astellas Pharma US, Inc., that an End of Review meeting with the U.S. Food & Drug Administration (FDA) has been scheduled for November 14th, 2008 regarding the New Drug Application (NDA) for KYNAPID(TM) (vernakalant hydrochloride) Injection for rapid conversion of atrial fibrillation to sinus rhythm. At the conclusion of FDA's review of an application and the issuance of an action letter, FDA provides applicants with an opportunity to meet with agency reviewing officials to discuss what further steps need to be taken by the applicant before the application can be approved.
Cardiome has also been informed by Astellas that, in an effort to align the North American regulatory strategy, Astellas has elected to withdraw the New Drug Submission (NDS) for KYNAPID with the Therapeutic Products Directorate (TPD) of Health Canada, originally submitted in May 2007. Cardiome and Astellas intend to revisit the Canadian regulatory strategy following resolution of the FDA process.
"Since receiving the FDA Approvable Letter in August, Cardiome and Astellas have been working diligently to collate information and analyses relevant to the issues raised in the action letter, and this meeting is intended to provide us with clear guidance so that we can focus our efforts on providing a robust response and attain U.S. approval for KYNAPID," said Bob Rieder, Chief Executive Officer of Cardiome. "We look forward to working with the FDA with the goal of having KYNAPID available to appropriate patients as soon as possible."<<