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FDA Modifies Boxed Warning For Gilead Sciences Letairis Drug; Monthly Tests No Longer Required


The U.S. Food and Drug Administration today announced that monthly liver enzyme tests are no longer required for those taking Letairis tablets (ambrisentan), used to treat high blood pressure in the vessels that carry blood to the lungs (pulmonary arterial hypertension, or PAH).

Citing data from clinical trials and postmarket reports, the FDA said that the drug poses only a low risk of liver injury. Information related to potential serious liver injury and the need to monitor for such serious injury is being removed from the drug's boxed warning.

Letairis is made by Gilead Sciences Inc. (NASDAQ: GILD).

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Posted-In: FDA


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