FDAnews Drug Daily Bulletin

New Cough and Cold Drug From Versalis Falls Short of FDA Approval

Aug. 10, 2017

Versalis failed to gain FDA approval for the newest in its line of extended-release prescription cough and cold medicines.

The FDA issued a complete response letter for the drug, CCP-08. Versalis did not identify the issues in its announcement, and did not respond to a request for information. The FDA issued a CRL in April for CCP-07, an earlier drug in the line of liquid products, for what Versalis said were similar concerns.

The first drug in the line, Tuzitsra XR (codeine polistirex and chlorpheniramine polistirex) won FDA approval in 2015. The products are being developed in collaboration with Tris Pharma.

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