Acthar PDUFA Date Delayed As FDA Reviews Post-Approval Commitments
This article was originally published in The Pink Sheet Daily
Executive Summary
Advisory committee had recommended trials on side effects, sustainability, dosing and safety for the infantile spasms indication, which the firm was concerned would be unethical.
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Questcor Gains Approval of Acthar for Infantile Spasms
Long prescribed off-label, the adrenocorticotropic hormone also gets an orphan designation, bringing seven years of market exclusivity.
Questcor Gains Approval of Acthar for Infantile Spasms
Long prescribed off-label, the adrenocorticotropic hormone also gets an orphan designation, bringing seven years of market exclusivity.
New Challenge For Acthar Is Labeling; Practitioners Disagree On Dosing
Having gathered an advisory committee's endorsement that Questcor Pharmaceutical's Acthar (corticotropin) is effective for treating infantile spasms - a common off-label use - the remaining challenge for FDA is determining how the drug should be used in that indication