Pharmanex raises "substantial" questions about FDA Cholestin decision, court states.
This article was originally published in The Tan Sheet
Executive Summary
PHARMANEX RAISES "SUBSTANTIAL" QUESTIONS ABOUT FDA CHOLESTIN DECISION, COURT concludes in a June 16 decision and order granting the company's motion for a preliminary injunction against the agency. Salt Lake City federal court Judge Dale Kimball granted the motion to lift the FDA ban on imports of Chinese red yeast rice for production of Cholestin in part on the basis that Pharmanex "has shown a substantial likelihood of success" on the merits by showing the existence of questions "so serious, substantial, difficult and doubtful as to make the issue ripe for litigation and deserving of more deliberate investigation."