BRIEF—FDA approves first generic versions of Letairis

The US Food and Drug Administration has approved multiple generics for Letairis (ambrisentan) tablets, a treatment for pulmonary arterial hypertension (PAH) originated by biotech major Gilead Sciences,

With the approval of these first generics, and their associated risk evaluation and mitigation strategy (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 agency noted.

The FDA also approved two shared system REMS programs for ambrisentan.

There are now two separate REMS programs for ambrisentan.

The first is known as the Ambrisentan REMS (formerly called the Letairis REMS) and is comprised of the reference listed drug (RLD) or brand sponsor (Letairis), as well as three abbreviated new drug applications (ANDAs, or generics).

The second program is currently comprised of one ANDA sponsor and is known as the PS-Ambrisentan REMS.

The PS signifies “parallel system” to assist in differentiating the programs within the market.