Athenex Loses FDA Fight Over Bulk Drug Substance Vasopressin (1)

Athenex will stop producing compounded vasopressin for patients with low blood pressure due to shock after a federal judge granted the FDA’s motion for summary judgment against the company on Aug. 1.

The Buffalo, N.Y.-based company sued the Food and Drug Administration after the agency announced March 4 that there is no clinical need for that version of the product, which treats patients with a form of shock in which the blood vessels dilate.

The U.S. District Court for the District of Columbia also denied Athenex’s motion for summary judgment in its favor, finding that the FDA’s exclusion of vasopressin ...