Promotional Materials for Zyflo CR Result in `Untitled’ Letter From Regulators

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 ...