The Food and Drug Administration (FDA) has approved generic versions of the endothelin receptor antagonist Letairis (ambrisentan; Gilead) for the first time. Ambrisentan is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): to improve exercise ability and delay clinical worsening; and in combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability.
The approval of the new generics also includes 2 separate REMS programs for ambrisentan. The first is the Ambrisentan REMS (formerly named the Letairis REMS), which consists of the reference listed drug and 3 abbreviated New Drug Applications (ANDAs). The second program is known as the PS-Ambrisentan REMS, this REMS is currently comprised of 1 ANDA sponsor. The PS-Ambrisentan REMS will allow ambrisentan to be filled in the retail setting, while the Ambrisentan REMS will continue to only utilize specialty pharmacies.
Prescribers and patients will need to ensure that they are enrolled in both REMS programs; those currently enrolled in the Letairis REMS will be automatically enrolled in the Ambrisentan REMS. All pharmacies that currently dispense Letairis will need to re-enroll into the Ambrisentan REMS for continued access; to dispense ambrisentan in the retail setting or to have access to all the generic manufacturers, pharmacies will need to enroll in the PS-Ambrisentan REMS as well.
The generic approvals were granted to Mylan Pharmaceuticals, Watson Laboratories, Sun Pharma Global, and Zydus Pharmaceuticals. Ambrisentan will be supplied in 5mg and 10mg tablets.
For more information visit FDA.gov.