WASHINGTON-- The Food and Drug Administration (FDA) granted Westbury, N.Y.-based Tishcon Corp. [www.tishcon.com] orphan drug status for its UbiQGel registered Coenzyme Q10 (CoQ10) product for the treatment of Mitochondrial Cytopathies (MC). [MC encompass a number of debilitating diseases that are caused by inherited defects or malfunctions of the mitochondria.]
The orphan drug designation allows Tishcon to begin clinical trials of UbiQGel on MC patients. The trials are expected to be completed in two years and will begin this fall.
"Once the clinical trials have been successfully completed, we will be able to obtain marketing approval from the FDA to distribute UbiQGel as an approved prescription drug for the treatment of Mitochondrial Cytopathies." said Raj Chopra, Tishcon president. "This is a rare and breakthrough designation for a dietary supplement."