FDA Sends Curex Untitled Letter Over Marketing Unapproved Drugs

The FDA issued an untitled letter to New York-based drugmaker Curex for marketing unapproved allergy drugs.

The agency said the company’s allergenic extracts, meant to be administered under the tongue as immunotherapies, were drugs that needed to go through the agency’s biologics license application (BLA) process.

The company’s website explained that its therapy is “a formulation of specific allergens” and that each compound is “customized to the individual patient based on their medical profile, test results and lifestyle needs.”

But licensed biological products may not be combined with other licensed biological products unless a license is obtained for the combined product, wrote Mary A. Malarkey, director of the Office of Compliance and Biologics Quality in the FDA’s Center for Biologics Evaluation and Research.