Alembic Pharmaceuticals Ltd on Wednesday said it has received final approval from the US health regulator for its generic version of Arformoterol Tartrate inhalation solution indicated for long-term treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease.
The approval by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) for Arformoterol Tartrate inhalation solution is for strength of 15 mcg (base)/2 mL unit-dose vial, the company said in a statement.
The approved ANDA is therapeutically equivalent to the reference-listed drug product (RLD), Brovana inhalation solution, 15 mcg/2 mL, of Sunovion Pharmaceuticals Inc, it added.
Arformoterol Tartrate inhalation solution is indicated for long-term, twice daily administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, the company said.
This ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies Pvt Ltd, it added. Citing IQVIA data, the company said Arformoterol Tartrate inhalation solution, 15 mcg (base)/2 mL unit-dose vial, had an estimated market size of USD 251 million for the 12 months ended December 2021.
Alembic said it has a cumulative total of 167 ANDA approvals (143 final approvals and 24 tentative approvals) from USFDA, including this second inhalational ANDA approval.
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