Alembic Pharma gets USFDA nod for Formoterol Fumarate Inhalation Solution

Written by Ruchika Sharma Published On 2021-11-23T12:52:19+05:30 | Updated On 7 Oct 2023 4:51 PM IST

Alembic Pharma gets USFDA nod for Formoterol Fumarate Inhalation Solution

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.

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.

Read also: Alembic Pharma JV Aleor Derma gets USFDA nod for Mupirocin Cream

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.

alembic pharmaalembic pharma newsusfdaformoterol fumarate inhalation solutionperforomist inhalation solutionmylanchronic obstructive pulmonary diseasecopdchronic bronchitisemphysema

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751