Avadel Pharmaceuticals PLC said the U.S. Food and Drug Administration has extended the review period of AV001 by three months.
The FDA accepted the new drug application for Avadel's hospital product candidate in May and granted it a priority review.
The Dublin-based company said it submitted additional information regarding the application in response to the regulator's request. The FDA categorized these submissions as a major amendment and will decide on Avadel's new drug application by Dec. 15.
Avadel CEO Greg Divis said if AV001 is approved, the extension will not impact the timeline for the U.S. launch, which is expected in the first quarter of 2020.
The pharmaceutical company did not disclose the indication for the product.
Avadel's share price was down 8.64% to $2.01 after market close Aug. 8.