Jazz Pharmaceuticals Files Complaint Against FDA for Decision on Avadel Pharmaceuticals' Lumryz
June 22 2023 - 5:59PM
Dow Jones News
By Denny Jacob
Jazz Pharmaceuticals on Thursday said its subsidiary filed a
complaint alleging that the Food and Drug Administration's
unlawfully approved Avadel Pharmaceuticals' new drug application
for Lumryz.
The biopharmaceutical company said in a regulatory filing, which
outlined their complaint, that the FDA acted outside of its
authority under the Orphan Drug Act. Jazz Pharmaceuticals said its
product Xywav had orphan drug exclusivity. It said that the FDA
approved Lumryz's new drug application and granted it orphan drug
exclusivity based on its own findings that it boosts patient care,
and is therefore clinically superior to Xywav and another drug it
produces, Xyrem. Both drugs treat cataplexy, or excessive daytime
sleepiness, in adults with narcolepsy.
Jazz Pharmaceuticals described Lumryz as an extended-release
reformulation of Xyrem.
The Ireland-based company said among the complaint's allegations
are that the FDA acted without lawful basis when it determined that
the dosing regimen for Lumryz makes a major contribution to patient
care.
The complaint was filed in the United States District Court for
the District of Columbia.
Write to Denny Jacob at denny.jacob@wsj.com
(END) Dow Jones Newswires
June 22, 2023 18:44 ET (22:44 GMT)
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