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FDA approves first generic alternatives to Letairis, REMS programs

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The FDA announced it has approved several generic versions of Letairis for the treatment of patients with pulmonary arterial hypertension.

In addition, two shared system risk evaluation and mitigation strategy (REMS) programs were approved which, according to a press release from the FDA, means there are now two separate REMS programs for ambrisentan that will aid in managing drug-associated risks.

The press release indicated that Ambrisentan REMS, formerly called the Letairis REMS, consists of the reference listed drug or brand sponsor (Letairis) and three abbreviated new drug applications (generics). The second program, known as the Parallel System-Abrisentan REMS, consists of one abbreviated new drug application sponsor, according to the release.

“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),” according to the release. “The FDA found that the separate REMS proposed by the generic manufacturer achieves the same level of safety as the REMS for the brand-name ambrisentan.”

Reference:

www.fda.gov