FDA requires more data for Arcalyst (Regeneron) for Gout Flares treatment - 03-Aug-2012
The FDA has again issued a Complete Response Letter for the supplemental Biologics License Application for Arcalyst (rilonacept) from Regeneron for subcutaneous use for the prevention of Gout Flares in patients initiating uric acid-lowering therapy. The agency has requested additional clinical data, as well as additional chemistry, manufacturing and controls information related to a proposed new dosage form.
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