Catalyst Alleges US FDA 'Facilitating' Off-Label Use With Jacobus' Ruzurgi Approval
Lawsuit seeking invalidation of rare disease treatment's approval in Lambert-Eaton myasthenic syndrome encompasses policy trifecta of exclusivity, drug pricing, and expanded access issues.
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US FDA Orphan Exclusivity Would Revert To Pre-Catalyst Status Under Senate Legislation
Federal court decision said the FDA cannot grant orphan exclusivity for subpopulations of a disease, which agency officials fear could damage pediatric rare disease drug development.
Legal Notebook: Catalyst’s Suit vs. FDA Is Tossed, Avonex Patent Invalidity Verdict Is Reinstated
Court finds US FDA did not impede Catalyst orphan exclusivity for Firdapse as it approved different indication for competing product. Biogen loses 10-year patent battle against competing multiple sclerosis drug makers.
FDA Broke Catalyst's Orphan Exclusivity Due To Pricing, Not Clinical, Concerns, Firm Claims
Suit against agency reveals internal discussions to approve Jacobus' Ruzurgi despite Catalyst's orphan exclusivity for the same drug; Sen. Bernie Sanders urged FDA to address price of Catalyst's Firdapse (amifampridine).