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Medicines Co. falls on not approvable letter

May 29, 2008 1:02 AM UTC

The Medicines Co. (NASDAQ:MDCO) lost $1.47 to $18.47 on Wednesday after receiving a not approvable letter from FDA for an sNDA for an additional dosing regimen of Angiomax bivalirudin to treat acute coronary syndrome (ACS) started in the emergency department. The company said the agency "indicated that the basis of their decision involved the appropriate use and interpretation of non-inferiority trials," including the Phase lll ACUITY trial, which formed the basis of the sNDA. The company said it "disagrees with the agency on these issues and has initiated discussions to address them." ...