Avadel Pharma says its sleep disorder drug remains under FDA review

  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.

https://whtc.com/2024/09/12/avadel-pharma-says-its-sleep-disorder-drug-remains-under-fda-review/