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Alembic Pharmaceuticals receives US FDA tentative approval for Macitentan tablets, 10 mg

The tentatively approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product Opsumit tablets, 10 mg, of Actelion Pharmaceuticals US, Inc

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Alembic Pharmaceuticals today announced that it has received tentative approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Macitentan tablets, 10 mg. The tentatively approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product Opsumit tablets, 10 mg, of Actelion Pharmaceuticals US, Inc, a company statement notified.

Macitentan tablets are an Endothelin Receptor Antagonist (ERA) indicated for the treatment of Pulmonary Arterial Hypertension (PAH, WHO Group I) to delay disease progression. Disease progression included death, initiation of intravenous (IV) or subcutaneous prostanoids, or clinical worsening of PAH (decreased six-minute walk distance, worsened PAH symptoms and need for additional PAH treatment). Macitentan tablets also reduced hospitalisation for PAH. It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses, it said.

Macitentan tablets, 10 mg have an estimated market size of $797 million for twelve months ending Decemeber 2021, according to IQVIA, the statement concluded.

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