Tuesday, May 17, 2022
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US FDA Approves Bronchoconstriction Drug of Alembic Pharmaceuticals

The Food and Drug Administration (FDA) of the United States has given the final approval to the Alembic Pharmaceuticals for the company’s Abbreviated New Drug Application (ANDA) for the Arformoterol Tartrate Inhalation Solution and because of this approval, the shares of the company has also increased.

The approved ANDA of Alembic Pharmaceuticals has been therapeutically equivalent to the reference listed drug product (RLD), along with the Brovana Inhalation Solution of the Sunovion Pharmaceuticals Inc. and the ANDA has also been co-developed in the partnership with the Orbicular Pharmaceutical Technologies.

The Arformoterol Tartrate Inhalation Solution has been a long-acting beta2-adrenergic agonist has been indicated for the long-term and the daily administration in the maintenance treatment of the bronchoconstriction in the patients along with the chronic obstructive pulmonary disease (COPD), which is also including chronic bronchitis and emphysema.

According to IQVIA, the Arformoterol Tartrate Inhalation Solution is having an estimated market size of 51 million dollars for twelve months ending in the month of December 2021. Alembic Pharmaceuticals is having a cumulative total of 167 ANDA approvals from the US FDA, which is also including the second inhalational approval of ANDA.

The company ‘Alembic Pharmaceuticals’ has been a vertically integrated research and development pharmaceutical company and the company also manufactures and markets the generic pharmaceutical products across the world.