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Endo International To Not Oppose Additional Stay Of FDA Litigation - Quick Facts

Endo International plc (ENDP) said Thursday that the U.S. Food and Drug Administration has requested a further stay of Endo's ongoing litigation against the FDA through March 15, 2019.

The 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, LLC, manufacturers the only vasopressin product currently approved by the FDA, Vasostrict. Endo noted that the suit was most recently stayed on January 7, 2019 for the duration of the government shutdown.

However, the FDA has now filed a motion, which Endo did not oppose, seeking a further stay of the suit through March 15, 2019. In that motion, the FDA states that it "expects to publish the final clinical need determination for vasopressin on or before March 15, 2019."

Endo noted that if the FDA's motion is granted, the litigation will be stayed through March 15, 2019, subject to Endo's right to move to lift the stay in the event of a significant change in circumstances.

In October 2017, two Endo subsidiaries, Par and Endo Par Innovation Company, LLC, sued the FDA in the U.S. District Court for the District of Columbia, challenging the agency's "Interim Policy" on bulk compounding as unlawful because it authorized bulk compounding of drugs, including vasopressin, where the applicable legal requirements, including a determination of clinical need, were not satisfied.

In January 2018 and March 2018, the parties agreed to stay the case while the FDA took initial steps to comply with the statutory framework. The parties then agreed in September 2018 to another stay of the litigation based on the FDA's representation that it would use its best efforts to finalize its clinical need determination for vasopressin by December 31, 2018.

Endo said that along with other interested parties, it has submitted comments on the FDA's proposed vasopressin determination. Due to the government shutdown, however, that determination did not occur by December 31, 2018 and the litigation was stayed for the duration of the shutdown.

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