FDA Advises Eurand (EURX) That It Has Extended the Review Period for ZENPEP(TM) Therapy
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Eurand N.V. (NASDAQ: EURX) announced that the U.S. FDA has advised the Company that it has extended the June 2009 user fee goal date for the New Drug Application for ZENPEP(TM) (pancrelipase capsules) by three months.
The FDA did not request that the Company provide any further information, but attributed the reason for the delay to the need for additional time to review the current submission.
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