Drug developer sues FDA over delayed decision on narcolepsy drug
A drug developer is suing the HHS, the FDA and both its chiefs, FDA Commissioner Robert Califf and HHS Secretary Xavier Becerra, over a yearlong delay in approving a narcolepsy drug.
Missouri-based Avadel CNS Pharmaceuticals filed the suit in US District Court in Washington DC accusing the agencies of stalling. The suit is based on whether the drug would infringe on one of the patents that protect Jazz Pharmaceuticals’ treatment for narcolepsy Xywav — which has been a primary treatment since 2002 and is distributed under a Risk Evaluation and Mitigation Strategy, or REMS.
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