Alembic Pharmaceuticals’ Bosentan Tablets, Generic to Tracleer, Approved by the FDA
A new generic version of Actelion’s Tracleer (bosentan), developed by Alembic Pharmaceuticals, has been approved by the U.S. Food and Drug Administration (FDA) for treating pulmonary arterial hypertension (PAH). The approval comes after Alembic submitted an abbreviated new drug application (ANDA) for generic bosentan tablets. ANDA is an application for…