Alembic Pharma gets US FDA approval for generic Tracleer tablets

Last Updated on February 12, 2023 by The Health Master

Alembic Pharmaceuticals Ltd has received final nod from United States Food & Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) Bosentan tablets, 62.5 mg and 125 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Tracleer tablets, 62.5 mg and 125 mg, of Actelion Pharmaceuticals Limited. 

Bosentan tablets is indicated for the treatment of pulmonary arterial hypertension.

Bosentan tablets, 62.5 mg and 125 mg have an estimated market size of US$ 68 million for twelve months ending September 2019, according to IQVIA.

Alembic has a cumulative total of 114 ANDA approvals from US FDA.

Also read: Alembic gets USFDA nod for Tizanidine HCL capsules

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