FDA Approves Letairis (Ambrisentan) Generics for PAH

Megan Brooks

April 01, 2019

The US Food and Drug Administration (FDA) has approved four generic versions of Gilead Sciences' Letairis (ambrisentan), an endothelin receptor antagonist indicated for treatment for pulmonary arterial hypertension (PAH).

The FDA first approved Letairis for PAH in 2007. Three generics are from Mylan Pharmaceuticals, Watson Laboratories, and Sun Pharma Global. The fourth generic is from Zydus Pharmaceuticals.

In order to accommodate all four generics, the FDA also approved two shared system risk evaluation and mitigation strategy (REMS) programs for generic ambrisentan, which means there are now two separate REMS programs for the drug.

One program called Ambrisentan REMS (formerly Letairis REMS) consists of the brand name drug (Letairis) for the three generics from Mylan, Watson, and Sun.

The other program for Zydus' generic version is called PS-Ambrisentan REMS. The PS signifies "parallel system" to help differentiate the programs within the market, the FDA said.

The PS-Ambrisentan REMS allows ambrisentan to be filled in the retail setting, while the Ambrisentan REMS will continue to only utilize specialty pharmacies.

With the approval of these first generics, and their associated REMS programs, "patients will now have access to additional products (brand-name and generic) and additional types of pharmacies to fill their prescriptions (retail or specialty)," the FDA said in a statement.

For patients to have access to generic ambrisentan, prescribers need to take the following actions:

  • Ensure patients are enrolled in both programs by enrolling in the PS-Ambrisentan REMS. Prescribers currently enrolled in the Letairis REMS will be automatically enrolled in the Ambrisentan REMS. This will allow patients to have access to both generic and branded ambrisentan and to receive their medication from multiple pharmacy types, depending on their insurance coverage.

  • Enroll current ambrisentan patients in the PS-Ambrisentan REMS. Patients currently enrolled in the Letairis REMS will be automatically transferred to the Ambrisentan REMS.

  • Enroll all future ambrisentan patients in both the Ambrisentan REMS and the PS-Ambrisentan REMS.

The FDA said pharmacies that dispense ambrisentan need to be aware of both REMS programs. Each program has procedural requirements specific to their REMS program.

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