Alembic Pharmaceuticals acquired very last approval from the USA Food & Drug Administration (USFDA) 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 equal to the
reference listed drug product (RlD), Brovana Inhalation Solution, 15 mcg/2 ml, of Sunovion Pharmaceuticals Inc. Arformoterol Tartarate Inhalation Solution is a longacting beta2-adrenergic agonist (beta2-agonist) indicated for lengthy-time period, twice day by day (morning and evening) management in the maintenance remedy of bronchoconstriction in patients with chronic obstructive pulmonary disorder (COPD), consisting of persistent bronchitis and emphysema.
This ANDA has been co-evolved in partnership with Orbicular Pharmaceutical Technologies Pvt Ltd.
Arformoterol Tartrate Inhalation Solution, 15 mcg (base)/2 ml Unit-dose Vial, has an estimated market length of US$ 251 million for 365 days ending Dec 2021 consistent with IQVIA.
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