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, 20 mcg/2 ml per Unit-Dose Vial. 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 lonqterm, 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.
Formoterol Fumarate Inhalation Solution, 20 mcg/2 ml per Unit-Dose Vial, has an estimated market size of US$ 310 million for twelve months ending Sep. 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.
Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 735.65 as compared to the previous close of Rs. 762.90. The total number of shares traded during the day was 67022 in over 3542 trades.
The stock hit an intraday high of Rs. 760.00 and intraday low of 724.40. The net turnover during the day was Rs. 49359826.00.