What is the PS-Ambrisentan Risk Evaluation and Mitigation Strategy (REMS)?

The PS-Ambrisentan Risk Evaluation and Mitigation Strategy (REMS) Program

A Risk Evaluation and Mitigation Strategy is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure that the benefits of the drug outweigh its risks.

The PS-Ambrisentan REMS is a safety program that manages the risk of serious birth defects when taking ambrisentan. The PS-Ambrisentan REMS is required by the Food and Drug Administration (FDA).

  • Only prescribers and pharmacies certified by the PS-Ambrisentan REMS can prescribe and dispense ambrisentan to patients
  • Patients must be enrolled in the PS-Ambrisentan REMS and follow all the safety rules in the REMS in order to receive ambrisentan.

ambrisentan

Cipla USA, Inc.

(866) 604-3268

69097-386-02 - 5mg

ambrisentan

Cipla USA, Inc.

(866) 604-3268

69097-387-02 - 10mg

ambrisentan

Zydus Pharmaceuticals (USA) Inc.

(877) 993-8779

70710-1179-3 - 5mg bottle of 30 tablets

ambrisentan

Zydus Pharmaceuticals (USA) Inc.

(877) 993-8779

70710-1180-3 - 10mg bottle of 30 tablets