Endo International PLC has asked a federal court to dismiss its October 2017 lawsuit against the U.S. Food and Drug Administration, which challenged the regulator's bulk compounding policy.
Under the Drug Quality and Security Act of 2013, licensed pharmacists are authorized to combine, mix or alter ingredients to develop medications specific to patients' needs that are not commercially available.
The FDA was evaluating vasopressin — an ingredient in Endo's blood pressure drug Vasostrict — to be placed on the list of bulk drug substances that can be used under the law. Dublin-based Endo challenged the inclusion of vasopressin on the list in the lawsuit.
Vasopressin was removed from the list by the FDA in March. However, that action was challenged in court by Athenex Inc. Endo and the FDA were co-defenders in the Athenex lawsuit, and a court later upheld the removal of vasopressin from the list.
Endo is now moving to withdraw its original litigation under an agreement with the FDA and the U.S. Department of Justice.
