Alembic Pharma gets US FDA approval for perforomist inhalation solution & dabigatran etexilate capsules

Alembic Pharmaceuticals Limited announced that it has received final approval from the US Food & Drug Administration (FDA) 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 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. 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 September 2021 according to IQVIA. The company also has received tentative approval from the US Food & Drug Administration (FDA) for its Abbreviated New Drug Application for dabigatran etexilate capsules, 150 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product pradaxa dabigatran etexilate mesylate capsules, Eq to 150 mg base, Boehringer Ingelheim. Dabigatran etexilate capsules are indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, and for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for 5 to 10 days. It is also indicated to reduce the risk of recurrence of DVT and PE in patients who have been previously treated. Dabigatran etexilate capsules, 150 mg have an estimated market size of US$ 410 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 US FDA.

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