A consent decree of permanent injunction was filed against Bio Health Solutions LLC, of Las Vegas and its manager and co-owner, Mark Garrison, for selling RenAvast, an unapproved animal drug, according to the FDA.
According to the complaint filed with the consent decree, the defendants have marketed RenAvast to treat diseases, including chronic renal failure, in cats and dogs. It is illegal to market new animal drugs without first requesting FDA pre-market review and obtaining legal marketing status.
The decree prevents Bio Health Solutions LLC and Garrison from introducing RenAvast and any other unapproved new animal drugs into interstate commerce. The firm would not be able to market the drug unless and until it obtains an approved new animal drug application or meets the requirements for an investigational new animal drug exemption.
The FDA previously issued a Warning Letter to Garrison regarding Bio Health Solutions LLC’smarketing of RenAvast in August 2012.