OPDP Comes out Swinging With A Warning Letter on Unsubstantiated Efficacy
FDA Law Blog
AUGUST 16, 2023
Breztri was approved just over 3 years ago in July 2020 for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). The indication includes a limitation of use that Breztri is not indicated for the relief of acute bronchospasm or for the treatment of asthma.
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