India Pharma Outlook Team | Wednesday, 11 May 2022
Alembic Pharmaceuticals Limited (Alembic) 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 Tartrate 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 collaboration with Orbicular Pharmaceutical Technologies Private Limited. For the twelve months ending December 2021, IQVIA estimated market size of US $251 million. Alembic has a cumulative total of 167 ANDA approvals (143 final approvals and 24 tentative approvals) from the USFDA, including this second inhalational ANDA approval.
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