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US FDA nod for Alembic’s ANDA

Our Bureau | | Updated on: Nov 23, 2021
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Formoterol Fumarate Inhalation Solution is used to treat chronic obstructive pulmonary disease

Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Formoterol Fumarate Inhalation Solution, used in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease.

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“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,” the company said in a stock exchange filing.

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In pact with Orbicular Pharma

This ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies Private Limited. Formoterol Fumarate Inhalation Solution, 20 mcg/2 ml per Unit-Dose Vial, has an estimated market size of $310 million for twelve months ending September 2021, according to IQVIA. Alembic has received year to date (YTD) 14 approvals (11 final approvals and 3 tentative approvals) and a cumulative total of 153 ANDA approvals (134 final approvals and 19 tentative approvals) from USFDA, including this first inhalational ANDA approval, the company added.

Published on November 23, 2021

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