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Catalyst Alleges US FDA 'Facilitating' Off-Label Use With Jacobus' Ruzurgi Approval

 
• By Derrick Gingery

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.

Firdapse and Ruzurgi both received orphan drug designations, which made Ruzurgi's approval complicated since it came after Firdapse. • Source: Shutterstock

A lawsuit alleges that a US Food and Drug Administration tentative approval letter actually encouraged off-label use of a rare disease treatment, creating competition for a product that had obtained temporary monopoly power.

Catalyst Pharmaceuticals Inc. sued the FDA on 12 June demanding that the approval of Jacobus Pharmaceutical Co.'s Ruzurgi (amifampridine)...

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