Savient’s Puricase For Gout Wins Priority Review
This article was originally published in The Pink Sheet Daily
Executive Summary
Targeted action date is April 30 for the orphan product, submitted for treatment-failure gout.
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FDA panel to weigh Savient’s Puricase for gout
FDA's Arthritis Drugs Advisory Committee will evaluate the BLA for Savient Pharmaceutical's Puricase (pegloticase) for the orphan indication of treatment-failure gout. Under priority review, the product's action date is April 20 1("The Pink Sheet" DAILY, Dec. 29, 2008). Late last year, the panel unanimously recommended Takeda's gout therapy febuxostat (2"The Pink Sheet" DAILY, Nov. 24, 2008)
FDA panel to weigh Savient’s Puricase for gout
FDA's Arthritis Drugs Advisory Committee will evaluate the BLA for Savient Pharmaceutical's Puricase (pegloticase) for the orphan indication of treatment-failure gout. Under priority review, the product's action date is April 20 1("The Pink Sheet" DAILY, Dec. 29, 2008). Late last year, the panel unanimously recommended Takeda's gout therapy febuxostat (2"The Pink Sheet" DAILY, Nov. 24, 2008)
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