Alembic Pharma gets final USFDA nod for Bosentan tablets to treat pulmonary arterial hypertension

New Delhi: Alembic Pharmaceuticals (Alembic) on Friday said it has received final nod from US health regulator for Bosentan tablets, used for treatment of pulmonary arterial hypertension. "Alembic Pharmaceuticals Ltd (Alembic) today announced it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Bosentan tablets, 62.5 mg and 125 mg," the firm said in a BSE filing.

Bosentan tablets is for the treatment of pulmonary arterial hypertension.

"ANDA is therapeutically equivalent to the reference listed drug product (RLD) Tracleer Tablets, 62.5 mg and 125 mg, of Actelion Pharmaceuticals Ltd," the filing said.

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

Alembic has a cumulative total of 114 ANDA approvals from USFDA.