September 25, 2017 / 1:56 PM / in 9 months

Intercept Pharma says possible Ocaliva boxed warning will not be restrictive

Sept 25 (Reuters) - Intercept Pharmaceuticals Inc said on Monday an update to the label of its liver drug, Ocaliva, could include a boxed warning to help ensure proper dosing of patients, but added that it did not expect the change to be restrictive.

A boxed warning is the strictest warning by the U.S. Food and Drug Administration (FDA) that appears on a drug’s label, calling attention to serious or life-threatening risks of a drug.

The FDA last week warned about Ocaliva being incorrectly dosed in some patients with a rare liver disease, increasing the risk of liver injury and death.

Intercept’s shares were up 5.5 percent at $65.00 in early trading on Monday. (Reporting by Manas Mishra in Bengaluru; Editing by Sai Sachin Ravikumar)

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below