Alembic Pharma gets USFDA final nod for Arformoterol Tartrate inhalation solution

11 May 2022 , 03:45 PM

Alembic Pharmaceuticals Limited on Wednesday has announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Arformoterol Tartrate Inhalation Solution, 15 mcg (base) /2 ml Unit-dose Vial.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RlD), Brovana Inhalation Solution, 15 mcg/2 ml, of Sunovion Pharmaceuticals Inc. Arformoterol Tartarate 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.

Arformoterol Tartrate Inhalation Solution, 15 mcg (base)/2 ml Unit-dose Vial, has an estimated market size of US$ 251 million for twelve months ending Dec 2021 according to IQVIA.

Further, Alembic has a cumulative total of 167 ANDA approvals (143 final approvals and 24 tentative approvals) from USFDA, including this second inhalational ANDA approval.

Alembic Pharmaceuticals ended at Rs724.90 apiece up by Rs4.65 or 0.65% on the BSE.