FDA extends review of Obeticholic Acid (Ocaliva) sNDA for primary biliary cholangitis

FDA extends review of Obeticholic Acid (Ocaliva) sNDA for primary biliary cholangitis

Submitted by admin on October 17, 2024 - 8:28pm
Source: 
HCP Live
News Tags: 
Ocaliva
Intercept Pharma
primary biliary cholangitis
FDA
Headline: 
FDA extends review of Obeticholic Acid (Ocaliva) sNDA for primary biliary cholangitis
snippet: 
  • The FDA extended its review of obeticholic acid's sNDA for PBC, with no new action date provided.
  • Obeticholic acid remains available under accelerated approval despite a negative advisory committee opinion on its clinical benefits.

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