FDA WARNING_LETTER - 4nrx.md - April 17, 2020

On May 13, 2020, the FDA issued a Warning Letter to www.4nrx.md following a website review on April 17, 2020. The FDA found the website selling unapproved and misbranded drugs, specifically lopinavir + ritonavir (marketed as "Hivus LR" and "Lopimune"), hydroxychloroquine sulfate (including "Plaquenil"), and ribavirin (marketed as "Ribasure"), with claims to mitigate, prevent, treat, diagnose, or cure COVID-19.

These products are deemed unapproved new drugs under section 505(a) of the FD&C Act, as no approved applications exist for their COVID-19 related uses or for the specific versions offered. They are also misbranded under section 502(f)(1) because they lack adequate directions for layperson use, and under section 503(b)(1) for being sold without a prescription, despite being prescription-only drugs. The FDA highlighted the risks of unapproved drugs, including contamination, counterfeiting, and varying active ingredient amounts. The agency also noted the FDA's caution against hydroxychloroquine/chloroquine use for COVID-19 outside of hospital settings or clinical trials due to serious heart rhythm risks.

The FDA demanded immediate cessation of sales of these unapproved and unauthorized products for COVID-19. The company must