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

Executive Summary

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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FDA Broke Catalyst's Orphan Exclusivity Due To Pricing, Not Clinical, Concerns, Firm Claims

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