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The Food and Drug Administration has approved multiple generics for ambrisentan (Letairis) tablets, as well as their associated risk evaluation and mitigation strategies (REMS), for patients with pulmonary arterial hypertension.
A total of four generics were approved, licensed to Mylan Pharmaceuticals, Sun Pharma Global, Watson Laboratories, and Zydus Pharmaceuticals. All four were approved at 5-mg and 10-mg doses. According to the label, the most common adverse events associated with ambrisentan include peripheral edema, nasal congestion, sinusitis, and flushing.
In addition to the generics, the FDA also approved two shared system REMS programs for ambrisentan. The first, Ambrisentan REMS, includes the brand sponsor and three abbreviated new drug applications. The FDA also approved two shared system REMS programs for ambrisentan. The first, Ambrisentan REMS, is composed of the brand sponsor and three abbreviated new drug applications. The second, PS-Ambrisentan REMS, is a parallel system and currently is constituted by one abbreviated new drug application.
“With the approval of these first generics ... patients will now have access to additional products (brand-name and generic) and additional types of pharmacies to fill their prescriptions,” the FDA said.
Find the full press release on the FDA website.
The Food and Drug Administration has approved multiple generics for ambrisentan (Letairis) tablets, as well as their associated risk evaluation and mitigation strategies (REMS), for patients with pulmonary arterial hypertension.
A total of four generics were approved, licensed to Mylan Pharmaceuticals, Sun Pharma Global, Watson Laboratories, and Zydus Pharmaceuticals. All four were approved at 5-mg and 10-mg doses. According to the label, the most common adverse events associated with ambrisentan include peripheral edema, nasal congestion, sinusitis, and flushing.
In addition to the generics, the FDA also approved two shared system REMS programs for ambrisentan. The first, Ambrisentan REMS, includes the brand sponsor and three abbreviated new drug applications. The FDA also approved two shared system REMS programs for ambrisentan. The first, Ambrisentan REMS, is composed of the brand sponsor and three abbreviated new drug applications. The second, PS-Ambrisentan REMS, is a parallel system and currently is constituted by one abbreviated new drug application.
“With the approval of these first generics ... patients will now have access to additional products (brand-name and generic) and additional types of pharmacies to fill their prescriptions,” the FDA said.
Find the full press release on the FDA website.
The Food and Drug Administration has approved multiple generics for ambrisentan (Letairis) tablets, as well as their associated risk evaluation and mitigation strategies (REMS), for patients with pulmonary arterial hypertension.
A total of four generics were approved, licensed to Mylan Pharmaceuticals, Sun Pharma Global, Watson Laboratories, and Zydus Pharmaceuticals. All four were approved at 5-mg and 10-mg doses. According to the label, the most common adverse events associated with ambrisentan include peripheral edema, nasal congestion, sinusitis, and flushing.
In addition to the generics, the FDA also approved two shared system REMS programs for ambrisentan. The first, Ambrisentan REMS, includes the brand sponsor and three abbreviated new drug applications. The FDA also approved two shared system REMS programs for ambrisentan. The first, Ambrisentan REMS, is composed of the brand sponsor and three abbreviated new drug applications. The second, PS-Ambrisentan REMS, is a parallel system and currently is constituted by one abbreviated new drug application.
“With the approval of these first generics ... patients will now have access to additional products (brand-name and generic) and additional types of pharmacies to fill their prescriptions,” the FDA said.
Find the full press release on the FDA website.