Endo Halts Lawsuit Against FDA Over Compounded Vasopressin

Endo Pharmaceuticals has chosen to delay its litigation against the FDA until the end of the year, to give the agency time to wrap up its promised rulemaking.

The Malvern, Pennsylvania-based drugmaker said that the FDA committed to using its best efforts to arrive at a final clinical need determination by Dec. 31, 2018, prompting the company to agree to an additional stay. The company’s lawsuit seeks the removal of its vasopressin from FDA’s category 1 nominations list, in order to keep outsourcing facilities from bulk compounding drugs that contain vasopressin.

Endo’s complaint argues that the FDA’s handling of bulk compounding laws violated the Drug Quality and Security Act when it treated the legislation as non-binding guidance instead of as a legal mandate. According to Endo, the agency ignored the law and chose to operate under a less rigorous “interim” program.