>>KING OF PRUSSIA, Pa., Jan. 22 /PRNewswire-FirstCall/ -- Vicuron Pharmaceuticals Inc. (Nasdaq: MICU; Nuovo Mercato) today announced that it has received notification from the U.S. Food & Drug Administration (FDA) that the agency now anticipates completing its review of the anidulafungin New Drug Application (NDA) on May 25, 2004, which represents a 90-day extension of the original action date. The company continues to expect the launch of anidulafungin, its novel hospital anti-fungal agent, in the first half of 2004 as planned. The company will hold a conference call and webcast this afternoon at 5:15 p.m. EST, (details below).
The extension was triggered by the agency's request for additional pharmacokinetic data. According to PDUFA (Prescription Drug User Fee Act), the FDA can reset the action date to review any additional data.
"We are working closely with the FDA to complete their review, which we expect will be within the revised timeframe," said Timothy J. Henkel, M.D., Ph.D., Vicuron's Chief Medical Officer. "We have been in close contact with the agency throughout the process, and it is our understanding that this extension is not related to any specific concerns regarding safety and efficacy and should therefore not impact our ability to launch anidulafungin according to plan."<<
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Cheers, Tuck |
