Alembic Pharmaceuticals Ltd on Tuesday said it has received final approval from the US Food & Drug Administration (USFDA) for its generic version of formoterol fumarate inhalation solution used for the treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease.
The approval for the abbreviated new drug application (ANDA) for formoterol fumarate inhalation solution is for 20 mcg/2 ml per unit-dose vial.
It is therapeutically equivalent to Mylan Specialty's 'Perforomist Inhalation Solution', 20 mcg/2 ml per unit-dose vial, Alembic Pharmaceuticals said in a regulatory filing.
The formoterol fumarate inhalation solution 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, it added.
"This ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies Pvt Ltd," the company said.
Citing IQVIA data, Alembic said formoterol fumarate inhalation solution, 20 mcg/2 ml per unit-dose vial, has an estimated market size of USD 310 million for twelve months ending September 2021.
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Alembic said it has 14 approvals (11 final approvals and 3 tentative approvals) year to date and a cumulative total of 153 ANDA approvals (134 final approvals and 19 tentative approvals) from USFDA, including this first inhalational ANDA approval.
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