With Zurampic, FDA Again Made Do With Sorry State Of Regulatory Science In Gout
Zurampic, which AstraZeneca licensed to Ironwood, pushed the limits of FDA's tolerance of the regulatory compromises agency has had to make in gout; our Drug Review Profile shows how statistician's case against approval received serious consideration, although the agency ultimately valued consistency with previous approvals in the space.
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Pricing for Duzallo, a fixed-dose combination of Zurampic (lesinurad) with generic allopurinol, will likely be on par with Zurampic's solo price tag of $371 per month to smooth the way with payers.
A year in our long-running series of deep dives into FDA review documents.