FDA WARNING_LETTER - Pronet/Eyal Bar Oz

The FDA issued a Warning Letter to Pronet/Eyal Bar Oz on September 18, 2012, for marketing unapproved and misbranded new drugs through numerous websites. The FDA's review determined that the websites offer products in violation of sections 301(a), 301(d), 502(a), 502(f), 503(b), and 505(a) of the FD&C Act.

The violations include offering unapproved new drugs such as "Viagra Professional," "Cialis Super Active," "Female Viagra," "Cialis Professional," "Viagra Soft," "Viagra," "Cialis," "Tamiflu," and "Baycip TZ." These products are considered new drugs without approved applications, violating sections 505(a) and 301(d). Specifically, "generic Tamiflu" is unapproved and misbranded as no FDA-approved generic exists, and Baycip TZ is entirely unapproved in the U.S.

Furthermore, the websites offer misbranded prescription drugs, some of which are controlled substances, without requiring a prescription from a licensed practitioner, violating section 503(b)(1). These drugs also lack adequate directions for use by a layman, making them misbranded under section 502(f)(1). The firm also sells unapproved and misbranded Accutane (