Avadel Pharma says its sleep disorder drug remains under FDA review

(Reuters) – Avadel Pharmaceuticals’ sleep disorder drug for use in pediatric patients seven years and older remains under review by the U.S. Food and Drug Administration, the company said in a regulatory filing on Thursday.

The health regulator was expected to make a decision by Sept. 7. Avadel did not provide details on a new action date.

(Reporting by Unnamalai L, Christy Santhosh and Bhanvi Satija in Bengaluru; Editing by Shailesh Kuber)