EvaPharmacy – FDA Warning Letter

The FDA issued a Warning Letter after reviewing numerous websites offering unapproved and misbranded new drugs for sale to U.S. consumers, violating sections 301(a), 301(d), 502(f), 503(b)(1), and 505(a) of the FD&C Act.

The websites offer "unapproved new drugs" such as "Levitra Super Force," "Viagra Super Force," and "Generic Celebrex." These products are considered drugs under section 201(g) and new drugs under section 201(p) because they are intended for disease treatment or to affect body structure/function and are not generally recognized as safe and effective. No approved applications exist for these products under section 505. Specifically, "Levitra Super Force" and "Viagra Super Force" contain dapoxetine, an unapproved active ingredient, and "Generic Celebrex" is marketed without an FDA-approved generic version.

Additionally, the websites offer "misbranded drugs" like clozapine and Avandaryl without requiring a prescription, violating section 503(b)(1). Clozapine is a prescription-only drug with significant risks, and both clozapine and Avandaryl have distribution restrictions that are not observed, leading to misbranding under section 502(f)(2) due to inadequate warnings.

The FDA