Alembic Pharmaceuticals receives USFDA final approvl for Arformoterol Tartrate Inhalation Solution

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 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 longacting 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.

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

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 720.25 as compared to the previous close of Rs. 725.30. The total number of shares traded during the day was 4238 in over 412 trades.

The stock hit an intraday high of Rs. 734.30 and intraday low of 714.00. The net turnover during the day was Rs. 3069680.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 ANDAApproval USFDA ArformoterolTartrateInhalationSolution