Cardiome Shares Drop As FDA Does Not Accept Marketing Application From Partner NEW YORK (AP) -- Shares of Cardiome Pharma Corp. dropped Wednesday after the Canadian drug developer said the Food and Drug Administration did not accept a marketing application filed by its partner Astellas Pharma US Inc.

Cardiome shares fell $2.94, or 26.1 percent, to $8.34 in premarket activity on the INET electronic exchange, after closing Tuesday at $11.28 on the Nasdaq. Over the past 52 weeks, the stock has traded between $5.28 and $14.45.

In late March, Astellas filed an application for the heart drug RSD1235 with the FDA, which then had 60 days to decide whether to accept the application or not. Cardiome said that the setback does not mean that RSD1235 is not an approvable drug. The FDA's letter said the application contained inconsistencies and omissions.

Cardiome said it will meet with Astellas and the FDA to discuss ways of making the application acceptable.

The setback also delays a $10 million milestone to Cardiome from Astellas conditioned on the FDA accepting the application.