>>Cardiome Announces Filing of New Drug Submission In Canada
Wednesday May 30, 11:50 am ET
VANCOUVER, May 30 /PRNewswire-FirstCall/ - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced that Astellas Pharma Canada, Inc., an affiliate of its co-development partner, Astellas Pharma US, Inc., has filed a New Drug Submission (NDS) with the Therapeutic Products Directorate of Health Canada seeking Canadian approval to market the intravenous formulation of vernakalant hydrochloride (vernakalant (iv)), an investigational new drug for the acute conversion of atrial fibrillation.
This filing follows the December 2006 submission of a New Drug Application (NDA) for vernakalant (iv) with the United States Food & Drug Administration (FDA), which is currently under review. Based on typical review periods, Cardiome expects to receive a decision from the FDA in October of 2007, and expects a decision from Health Canada in mid-2008.
In October 2003, Cardiome granted Astellas Pharma US, Inc. an exclusive license to develop and commercialize vernakalant (iv) in North America. The companies have co-developed vernakalant (iv) to NDA, with Astellas responsible for 75% of development costs. Cardiome has retained all rights to the intravenous formulations outside of Canada, U.S. and Mexico.<<
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Widely expected, I guess; the stock is not responding. Clear!
Cheers, Tuck |
