The Food and Drug Administration has told Cornerstone Therapeutics Inc. that a webpage and visual aid for Zyflo CR (zileuton extended-release tablets) are false or misleading because they omit important risk information, make unsubstantiated superiority claims, and omit material facts about the drug, according to an “untitled” letter posted July 6 on FDA’s website.
Zyflo CR is indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older, FDA said. It is not indicated for use in the reversal of bronchospasm in acute asthma attacks.
The prescribing information for Zyflo CR includes ...
Learn more about Bloomberg Law or Log In to keep reading:
See Breaking News in Context
Bloomberg Law provides trusted coverage of current events enhanced with legal analysis.
Already a subscriber?
Log in to keep reading or access research tools and resources.