PHA’s Understanding of Two Ambrisentan REMS Programs

This summary represents PHA’s best, current understanding of how the Ambrisentan REMS Program and PS-Ambrisentan REMS program are working. Since the landscape continues to evolve, PHA is learning along with all of you. If you have concrete information that appears to be different from something in this article, please share it with PHA.

  • There are now eight or more companies who have received approval from FDA to manufacture ambrisentan.
  • There are now two REMS programs for Ambrisentan:
  • Both programs have been authorized by FDA. Manufacturers choose which program to be associated with. FDA requires these manufacturers to work together to develop shared REMS requirements.
  • Manufacturers associated with the Ambrisentan REMS Program have chosen to have their product handled exclusively by specialty pharmacies. Manufactures associated with the PS-Ambrisentan REMS Program may distribute through specialty pharmacies or retail pharmacies.
  • Prescribers and patients enrolled in the former Letairis REMS Program should have been automatically transitioned to the Ambrisentan REMS Program. No automatic transition took place to the PS-Ambrisentan REMS Program.
  • FDA encourages patients and providers to be enrolled in both programs for easy of transition between generic formulations however no patient or provider is required to enroll in both programs.
  • Specialty pharmacies may not require patients and providers to enroll in the PS-Ambrisentan REMS Program. While some specialty pharmacies may prefer to distribute a generic product associated with the PS-Ambrisentan REMS Program, they also have access to products associated with the Ambrisentan REMS Program and should continue to serve patients enrolled in this program.

More information about the Ambrisentan REMS Program is available at https://ambrisentanrems.us.com/#Main

More information about the PS-Ambrisentan REMS Program is available at  https://www.psambrisentanrems.com/

PHA’s Treatment Access Program can be reached at gro.notaicossAHP@ecnarusnI or 301-565-3004 x749.