New Tool: ProSource
Checkout our packaging and processing solutions finder, ProSource.

Veterinary kidney drug crackdown

The FDA alleges that RenAvast was illegally marketed to treat diseases, including chronic renal failure, in cats and dogs.

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.

Discover Our Content Hub
Access Healthcare Packaging's free educational content library!
Read More
Discover Our Content Hub
Discover the right packaging solutions for life sciences in Philadelphia
Explore innovative packaging and supply chain solutions for the life sciences at the largest PACK EXPO East in history, March 18–20. Get ideas from 400+ top exhibitors and connect with colleagues and industry experts—all in one convenient location!
Read More
Discover the right packaging solutions for life sciences in Philadelphia