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Alembic Pharma announces US FDA final approval for Arformoterol Tartrate Inhalation Solution

The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product Brovana Inhalation Solution, 15 mcg/2 mL, of Sunovion Pharma

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Alembic Pharma today announced that it has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Arformoterol Tartrate Inhalation Solution, 15 mcg (base)/2 mL unit-dose vial. The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product Brovana Inhalation Solution, 15 mcg/2 mL, of Sunovion Pharma, Alembic Pharma said in a statement.

Arformoterol Tartarate Inhalation Solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with Chronic Obstructive Pulmonary Disease (COPD), including chronic bronchitis and emphysema, the statement added.

It also said that this ANDA has been co-developed in partnership with Orbicular Pharma.

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