Alembic Pharma Gets Final U.S. FDA Nod For Generic Version Of Arformoterol Tartrate Inhalation Solution

Alembic Pharmaceuticals Ltd. on Wednesday said it has received final approval from the U.S. 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 U.S. Food & Drug Administration for the abbreviated new drug application 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, 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, including chronic bronchitis and emphysema, the company said.

This ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies Pvt., 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 $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 U.S. FDA, including this second inhalational ANDA approval.