Oral Prescription Drugs Offered for Relief of Symptoms of Cough, Cold, or Allergy; Drug Efficacy Study Implementation; Caramiphen Edisylate; Final Actions on Supplemental New Drug Applications

摘要

The Food and Drug Administration (FDA) refuses to approve supplemental new drug applications (NDA's) for Tuss-Ornade Spansules and Liquid containing caramiphen edisylate and phenylpropanolamine hydrochloride. The basis for FDA's refusal to approve these products is that there is a lack of substantial evidence that caramiphen edisylate is effective.