Monday, June 11, 2007

FDA Approves Extended-Release Zyflo

The FDA has approved an extended-release formulation of the asthma drug, Zyflo (zileuton), the manufacturer announced.

The leukotriene synthesis inhibitor is approved for the prevention and chronic treatment of asthma in patients ages 12 and older and will be marketed as Zyflo CR, beginning in the fall. The recommended dosage is two 600-mg tablets twice a day.

Zyflo CR is contraindicated in patients with active liver disease or elevated liver enzymes. The manufacturer reminds physicians to measure patients' liver enzyme levels before beginning treatment and at regular intervals thereafter.

JW June 2007

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