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DUBLIN Endo International plc (“Endo”) (NASDAQ: ENDP) today announced the successful culmination of two litigation matters before the U.S. District Court for the District of Columbia regarding the unlawful compounding of vasopressin from bulk drug substances.
In October 2017, Endo initiated a lawsuit against the U.S. Food and Drug Administration (“FDA”) challenging the FDA’s interim policy authorizing the bulk compounding of drugs. That policy relied on “enforcement discretion” to allow bulk compounding of vasopressin, the active ingredient in Vasostrict®, which is manufactured by Endo’s subsidiary Par Sterile Products, LLC. Endo’s lawsuit alleged that the FDA’s interim policy violated Section 503B of the Drug Quality and Security Act (“DQSA”) and other provisions of the Federal Food, Drug, and Cosmetic Act which allow bulk compounding only if FDA first makes a determination that there is a genuine “clinical need” for compounding from a particular bulk drug substance.