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Opioid Analgesic REMS Letters

Click on the letter title below to open a PDF version of that letter.

Dear Healthcare Provider (HCP) Letter #1
Dear Healthcare Provider (HCP) Letter #2
Dear Professional Society and Licensing Board (PSLB) Letter #1
Dear Professional Society and Licensing Board (PSLB) Letter #2

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Last Updated: May 22 2025

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REMS Changes

The Ambrisentan REMS is a shared system REMS for approved ambrisentan products associated with this REMS, including Letairis, replacing the Letairis REMS Program. Prescribers currently certified and patients currently enrolled in the Letairis REMS Program will be transitioned from the Letairis REMS Program to the Ambrisentan REMS without the requirement to recertify or reenroll in the Ambrisentan REMS. Currently certified outpatient pharmacies in the Letairis REMS Program that are transitioning to the Ambrisentan REMS will be required to recertify in the Ambrisentan REMS.