JAZZ PHARMACEUTICALS, INC. v. BECERRA et al
Case Number:
1:23-cv-01819
Court:
Nature of Suit:
Administrative Procedure Act/Review or Appeal of Agency Decision
Judge:
Firms
Companies
Government Agencies
Sectors & Industries:
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October 30, 2024
FDA Didn't Flub Approval In Orphan Drug Case, DC Court Says
The U.S. Food and Drug Administration didn't err in determining that a rival narcolepsy treatment is not the "same drug" as Jazz Pharmaceuticals' exclusive treatment, a D.C. federal judge ruled Wednesday, holding that the FDA's approval of the rival drug didn't run afoul of the Orphan Drug Act.
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May 10, 2024
Pharma Cos., FDA Debate 'Same Drug' In Orphan Drug Case
Two pharmaceutical companies and the U.S. Food and Drug Administration faced off in D.C. federal court Friday over allegations that the federal agency wrongly approved a treatment that rivals Jazz Pharma's narcolepsy drug despite Jazz's exclusivity rights under the Orphan Drug Act.
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June 22, 2023
Jazz Pharma Says FDA Again Defied Orphan Drug Exclusivity
Jazz Pharma on Thursday asked a D.C. federal judge to block the U.S. Food and Drug Administration's "unlawful" approval of a rival narcolepsy treatment despite Jazz's exclusivity rights under the Orphan Drug Act, arguing that it showcases the FDA's "stark refusal" to implement the ODA as it should.