Alembic Pharma bags USFDA nod for Arformoterol Tartrate Inhalation Solution
This ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies Private Limited.;
Vadodara: Drugmaker, Alembic Pharmaceuticals Limited, today announced that the company has received final approval from the US 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 equivalent 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 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.
This ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies Private Limited.
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