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

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.

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

Tags:    

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News