Asthma

FDA approves Zyflo for prevention and treatment of asthma

Published in Medical Letter on the CDC and FDA, November 6th, 2005

Critical Therapeutics, Inc., (CRTX) announced that the U.S. Food & Drug Administration (FDA) has approved the company's supplemental new drug application (sNDA) to manufacture and market Zyflo (zileuton tablets), which is indicated for the prevention and chronic treatment of asthma in patients 12 years of age and older.

There were no material changes to the prescribing information insert for Zyflo as a result of the FDA review. Zyflo is expected to be available to patients before the end of October 2005.

According to the company, Zyflo is the only FDA-approved asthma treatment that inhibits the production of 5-lipoxygenase (5-LO), the main enzyme...

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Source: Medical Letter on the CDC and FDA (2005-11-06)

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