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Avadel's hospital product candidate accepted for priority review by US FDA
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Avadel Pharmaceuticals PLC said the U.S. Food and Drug Administration accepted the new drug application for the company's hospital product candidate AV001 and granted it priority review.
The U.S. regulator will decide on Avadel's product candidate by Sept. 15. The Dublin-based company did not disclose what indication the product will be used for.