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Shares of Avadel Pharmaceuticals (NASDAQ: AVDL) are down 14% as of 1:29 p.m. EDT today after the Food and Drug Administration said it would need more time than originally thought to review FT218 -- Avadel's candidate to treat narcolepsy.
After accepting a company's approval filing, the FDA provides applicants with a date known as the Prescription Drug User Fee Amendments date -- or PDUFA date . It's intended to give drugmakers insight into the review timeline.