Endo International has applauded the U.S. District Court for the District of Columbia's decision supporting the Food and Drug Administration's (FDA) determination that vasopressin cannot be used for compounding by outsourcing facilities. The Court specifically concluded that the FDA's decision to exclude vasopressin from the "clinical need" list was consistent with the applicable statutory scheme and was otherwise not "arbitrary and capricious."
In March 2019, the FDA determined that there is no clinical need to compound vasopressin under Section 503B of the Drug Quality and Security Act. As a result, it is unlawful for outsourcing facilities to sell compounded vasopressin products unless they manufacture those products using an FDA-approved vasopressin product, rather than bulk vasopressin, or if vasopressin were to be added to the FDA's drug shortage list. Par Sterile Products, LLC ("Par"), a subsidiary of Endo, is the manufacturer of Vasostrict®, the only vasopressin product approved by the FDA. Following the FDA's decision, Athenex, Inc. and two of its affiliates sued the FDA seeking to overturn the vasopressin decision. Par and another Endo subsidiary intervened as defendants in the action.
"At Endo, delivering high quality products and ensuring patient safety are our top priorities and we are very pleased with the district court's decision confirming the FDA's determination that there is no clinical need to bulk compound vasopressin," said Matthew J. Maletta, Executive Vice President and Chief Legal Officer of Endo.