FDA Rejects Caramiphen Edisylate NDA for Cough, Cold, and Allergy Relief

Summary

The FDA has denied supplemental new drug applications for Tuss-Ornade Spansules and Liquid containing caramiphen edisylate and phenylpropanolamine hydrochloride, citing insufficient evidence of caramiphen edisylate's efficacy in treating cough, cold, and allergy symptoms.