Endo intervened in the Athenex lawsuit to defend the case alongside the FDA and the Department of Justice. District Court in the District of Columbia-seeking to invalidate the FDA's decision regarding vasopressin.

Soon thereafter, a bulk compounder of vasopressin, Athenex, Inc., and two related entities (collectively, ' Athenex'), sued the FDA-also in the U.S. FDA ultimately finalized its new guidance and issued a thorough, well-reasoned administrative decision that bulk compounders of vasopressin competing with Vasostrict ® could not satisfy the statutory 'clinical need' requirement. At FDA's and the Department of Justice's request, Endo stayed its lawsuit to allow FDA time to complete this process. Shortly after Endo filed its lawsuit, the FDA began to take significant steps to implement the requirements of the DQSA, and in particular issued proposed guidance regarding the statutory 'clinical need' requirement which was consistent with the claims in Endo's Complaint. 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. 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. Food and Drug Administration (' FDA') challenging the FDA's interim policy authorizing the bulk compounding of drugs. In October 2017, Endo initiated a lawsuit against the U.S. District Court for the District of Columbia regarding the unlawful compounding of vasopressin from bulk drug substances. The data presented on this page does not represent the view of Endo Pharmaceuticals Inc and its employees or that of Zippia.Įndo Pharmaceuticals Inc may also be known as or be related to ENDO HEALTH SOLUTIONS INC., Endo Health Solutions Inc, Endo Health Solutions Inc., Endo International plc, Endo Pharmaceuticals and Endo Pharmaceuticals Inc.DUBLIN, Sept. 30, 2019 /PRNewswire/ - Endo International plc (' Endo') (NASDAQ: ENDP) today announced the successful culmination of two litigation matters before the U.S.

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