Alembic Pharma gets USFDA nod for Formoterol Fumarate Inhalation Solution

Published On 2021-11-23 07:22 GMT   |   Update On 2023-10-07 11:21 GMT
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Mumbai: Drugmaker, Alembic Pharmaceuticals Limited, today announced that the company 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.

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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 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.

Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company headquartered in Gujarat.

Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.

Read also: Alembic Pharma JV Aleor Derma secures USFDA approval for Metronidazole Gel

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