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Vernalis cough cold treatment rejected by US FDA

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Vernalis cough cold treatment rejected by US FDA

The U.S. Food and Drug Administration rejected Vernalis PLC's new drug application, or NDA, for its cough cold treatment CCP-08.

The company said items that resulted in a previous U.S. FDA rejection for a different cough cold treatment, CCP-07, were not addressed in time to avoid the same outcome for CCP-08.

Vernalis is working to resubmit NDAs for CCP-07 and CCP-08. Both treatments are products of a licensing and collaboration deal with Tris Pharma Inc. to develop cough cold treatments for the U.S. market.