The FDA previously determined there was no clinical need to compound vasopressin. The U.S. District Court for the District of Columbia recently supported the FDA decision. This is great news for Endo.
Endo International plc (“Endo”) today 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.
ENDP has been in free fall over the past year. The stock hit another 52-week low Thursday. The stock is facing headwinds from a few issues, real or imagined. That could change shortly. Read more: