A U.S. district court has ruled in the FDA's favor in a lawsuit brought by Athenex (NASDAQ:ATNX) over the agency's March decision not to include vasopressin on its approved bulk compounding list. As a result, the company will cease production and marketing of its compounded vasopressin product until allowed to do so.
It launched vasopressin, a diuretic, in ready-to-use premix IV bags in the U.S. in August.
Update: In a statement, the FDA explains that it excluded vasopressin from the bulk compounding list because there is already an FDA-approved product on the market that meets patients' needs, a decision affirmed by the court.
Subscribe for full text news in your inbox