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.
You may also be interested in...
A Matter Of Precedent: US FDA Sometimes Labors Under Weight Of Unpopular Or Unfavorable Decisions
As agency observers wonder whether and how political considerations will impact the timing of a COVID-19 vaccine approval or authorization, the Pink Sheet looks at instances through the years where agency staffers found themselves operating under precedents with which they disagreed or that didn’t work out as expected.
Duzallo Approval Opens Gout Opportunity For Ironwood
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.
Drug Review Profiles: Behind The Scenes At US FDA
A year in our long-running series of deep dives into FDA review documents.