Endo announces FDA requested further stay of ongoing litigation

Endo International announced that the FDA has requested a further stay of Endo’s ongoing litigation against the FDA through March 15. 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 on January 7 for the duration of the government shutdown.
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