Alembic Pharma gets USFDA nod for Formoterol Fumarate Inhalation Solution
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Mumbai: 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 Formoterol Fumarate Inhalation Solution, 20 mcg/2 mL per Unit-Dose Vial.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Perforomist Inhalation Solution, 20 mcg/2 mL per Unit-Dose Vial, of Mylan.
Specialty, L.P. Formoterol Fumarate 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.
This ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies Private Limited.
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