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Dark Skies For Ocaliva: US FDA Sides With AdComm In Complete Response Letter

 
• By Bridget Silverman

The US FDA rejected Intercept’s bid to convert Ocaliva’s accelerated approval in primary biliary cholangitis, meaning withdrawal prospects loom.

Storms may be on the horizon for Intercept after Ocaliva received a complete response letter from the FDA in primary biliary cholangitis. (Shutterstock)

One of the last lines of defense against withdrawal of Ocaliva’s accelerated approval failed when the US Food and Drug Administration issued a complete response letter for Intercept Pharmaceuticals’ bid for full approval in primary biliary cholangitis with confirmation of clinical benefit.

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