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).

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Drug pricing was backdrop for FDA approval of Ruzurgi.

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