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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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.
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.
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).