Subscribe to our Newsletters !!
HiGenoMB® Molecular Biology Division o
Telstar has developed a new sensor capable of moni
The virus outbreak i.e. monkey pox, has off late b
Micromeritics announced three significant new inve
Alembic Pharmaceuticals Limited (Alembic) today an
Following the success of the promotion and informa
Chromogenic culture media are used to isolate, ide
11 May 2022, Mumbai: Alembic Pharmaceuticals Limited (Alembic) today 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 Tartarate 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.
Arformoterol Tartrate Inhalation Solution, 15 mcg (base)/2 mL Unit-dose Vial, has an estimated market size of US$ 251 million for twelve months ending Dec 2021 according to IQVIA.
Alembic has a cumulative total of 167 ANDA approvals (143 final approvals and 24 tentative approvals) from USFDA, including this second inhalational ANDA approval.
