FDA shoots down Mallinckrodt's redemption attempt, spurns rare kidney disease drug for a second time
Whatever hope Mallinckrodt had following a narrow recommendation by the FDA advisory committee to approve terlipressin has been dashed by a firm rejection.
The complete response letter stabbed right through the UK drugmaker’s case for the drug, as regulators are asking for “more information to support a positive risk-benefit profile for terlipressin” as a treatment of the rare kidney disease known as hepatorenal syndrome type 1, or HRS-1.
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