(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)
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