trending Market Intelligence /marketintelligence/en/news-insights/trending/qfraVNSyakY_-obbEcb70A2 content esgSubNav
In This List

Avadel hospital drug's review period extended by US FDA

Case Study

Identifying PPE Suppliers During the Pandemic


Highlighting the Top Regional Aftermarket Research Brokers by Sector Coverage


COVID-19 Impact & Recovery: Healthcare Outlook for H2 2021


Corporate Credit Risk Trends in Developing Markets: A Loss Given Default (LGD) Perspective

Avadel hospital drug's review period extended by US FDA

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.