Endo International (NASDAQ:
ENDP)
gains 2.2% in premarket trading after the culmination of
two litigation matters regarding the compounding of vasopressin from bulk drug substances.
Vasopressin is the active ingredient in Vasostrict, which is made by Endo’s subsidiary Par Sterile Products.
In October 2017, Endo sued the U.S. Food and Drug Administration, saying the FDA’s interim policy authorizing the bulk compounding of drugs violated a law that only allows bulk compounding if the FDA first makes a determination that there is a genuine “clinical need” for compounding from a particular bulk drug substance.
FDA ultimately finalized new guidance and issued a decision that bulk compounders of vasporessin competing with Vasostrict could not satisfy the statutory “clinical need” requirement.
Soon after that, Athenex and two related entities sued the FDA, seeking to invalidate that decision. Endo intervened in that suit to defend the case along with the FDA and Department of Justice. The court decision in the case prohibits Athenex from selling its product and denied a motion for a stay of the ruling pending appear.
“In light of FDA’s determination that bulk compounding of vasopressin is impermissible under Section 503B and the Court’s decision to uphold that determination, we have agreed with the Department of Justice and the FDA to voluntarily dismiss Endo’s lawsuit,” said Matthew J. Maletta, Endo’s chief legal officer.
