Further stay of US compounding litigation due to government shutdown

Endo International (Nasdaq: ENDP) today announced that, due to the ongoing federal government shutdown, the US Food and Drug Administration has requested a further stay of Endo's ongoing litigation against the FDA for the duration of the shutdown.

That litigation challenges the FDA's authorization of the bulk compounding of drugs, including vasopressin, that have not satisfied the legal requirements under Section 503B of the Drug Quality and Security Act amendments to the Federal Food, Drug, and Cosmetic Act.

One of Endo's subsidiaries, Par Sterile Products, manufacturers the only vasopressin product currently approved by the FDA, Vasostrict. The suit was most recently stayed until December 31, 2018 and the FDA had committed to use its best efforts to issue a final clinical need determination for vasopressin on or before that date.