Jazz Pharmaceuticals Sues FDA Over Approval Of Rival Product, Calls It 'Unlawful'
Portfolio Pulse from Vandana Singh
Jazz Pharmaceuticals has filed a lawsuit against the FDA for approving Avadel Pharmaceuticals' Lumryz, claiming it violates the orphan drug exclusivity of Jazz's Xywav. Jazz alleges that the FDA acted outside its authority under the Orphan Drug Act.
June 23, 2023 | 11:57 am
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Jazz Pharmaceuticals is suing the FDA over the approval of Avadel Pharmaceuticals' Lumryz, claiming it violates the orphan drug exclusivity of Jazz's Xywav.
The lawsuit against the FDA could negatively impact Avadel Pharmaceuticals' stock price in the short term, as it creates uncertainty around the approval of its Lumryz product and potential legal challenges.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100
NEGATIVE IMPACT
Jazz Pharmaceuticals is suing the FDA over the approval of Avadel's Lumryz, claiming it violates the orphan drug exclusivity of Jazz's Xywav.
The lawsuit against the FDA could negatively impact Jazz Pharmaceuticals' stock price in the short term, as it creates uncertainty around the company's legal position and the future of its Xywav product.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100