Novartis: FDA accepts Sandoz latest regulatory submission.
(CercleFinance.com) - Sandoz said late on Thursday that the US Food and Drug Administration (FDA) has accepted its new drug application for a generic version of Glaxo's Advair Diskus.
If approved, the product will treat asthma in patients aged four years and older, in addition to providing maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD), Novartis' generics unit said.
Sandoz said it has gained additional expertise in the development of orally inhaled medicines since it acquired Oriel Therapeutics in 2010.
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If approved, the product will treat asthma in patients aged four years and older, in addition to providing maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD), Novartis' generics unit said.
Sandoz said it has gained additional expertise in the development of orally inhaled medicines since it acquired Oriel Therapeutics in 2010.
Copyright (c) 2017 CercleFinance.com. All rights reserved.