NEW YORK - Drug developer Eurand NV said Tuesday it expects the Food and Drug Administration to take an additional quarter to make a decision on its lead drug candidate because of a raw materials supplier's timeline.
| EURX | 7.01 |
In June, the FDA asked for additional information on the drug candidate Zentase, aimed at treating Exocrine Pancreatic Insufficiency, a condition where the pancreas stops producing and secreting enough digestive enzymes. While the company has already responded to the request, its raw materials supplier will not respond for several weeks.
Eurand now expects a decision on the drug during the first quarter of 2009 instead of in the fourth quarter of 2008.
Shares of Netherlands-based Eurand fell 52 cents, or 2.8 percent, to $17.98 in morning trading. The stock has traded between $11.38 and $19.60 over the past 52 weeks.
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