Endo Claims Win in Vasopressin Compounding Case

Endo says it is voluntarily withdrawing its 10/2017 suit against FDA challenging the agency’s interim policy authorizing bulk compounding of drugs that relied on enforcement discretion to allow bulk compounding of vasopressin, the active ingredient in Vasostrict, manufactured by Endo’s Par Sterile Products subsidiary. Endo says the suit is being withdrawn because FDA developed a “well-reasoned administrative decision that bulk drug compounders of vasopressin competing with Vasostrict could not satisfy the ‘clinical need’ requirement in the Drug Quality and Security Act.” That decision was challenged by Athenex and two related entities and the DC federal court ruled 8/1 that FDA’s exclusion of vasopressin from the clinical need list was not arbitrary and capricious and thus Athenex was barred from selling its product. Athenex had announced an appeals but now has withdrawn it, Endo says.