Alembic Pharmaceuticals has received Tentative Approval from the USFDA for Macitentan Tablets, 10 mg
Alembic Pharmaceuticals Limited announced that its Abbreviated New Drug Application (ANDA) for Macitentan Tablets, 10 mg has gained provisional approval from the US Food & Drug Administration (USFDA). Endothelin receptor antagonist (ERA) Macitentan Tablets are used to halt the progression of pulmonary arterial hypertension (PAH, WHO Group I). It also reduced the number of PAH hospitalisations but due to the RLD's pending exclusivity for such usage, it may not be advised for certain other purposes. reference listed drug product (RLD) Opsumit Tablets, 10 mg (Actelion)
