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Endo Lifts Temporary Stay Of Litigation Against FDA - Quick Facts

Endo International plc (ENDP) announced the company is lifting a temporary stay of its litigation against the U.S. FDA. The company said the litigation seeks a declaration that FDA's "Interim Policy" on compounding using bulk drug substances under Section 503B of the Drug Quality and Security Act of 2013 amendments to the Federal Food, Drug, and Cosmetic Act is contrary to law because it authorizes bulk compounding of new drugs where the applicable DQSA requirements are not satisfied and because it is fundamentally inconsistent with the plain language and structure of the FDCA statutory regime for introducing new drugs.

The litigation also seeks the immediate removal of vasopressin from FDA's Category 1 nominations list to assure that outsourcing facilities do not engage in bulk compounding of vasopressin-containing drug products under Section 503B.

Matthew Maletta, Chief Legal Officer of Endo, said: "We previously stated that in the event an entity were to commence bulk compounding of vasopressin under Section 503B prior to FDA's implementation of a new compounding policy, we would lift the stay of our litigation against FDA. Yesterday we did just that, and we will file a motion for preliminary injunction vacating the listing of vasopressin on FDA's Category 1 bulk drug substances list and preventing FDA from authorizing bulk compounding using vasopressin in a manner that does not comply with applicable laws."

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