Endo Agrees Not To Oppose Additional Stay of FDA Litigation Following Restoration of Government Appropriations
Endo International plc - Ordinary Shares (ENDP)
Last endo international plc - ordinary shares earnings: 2/26 06:00 am
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US:NASDAQ Investor Relations:
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Source: PR Newswire
DUBLIN, Feb. 7, 2019 /PRNewswire/ -- Endo International plc ("Endo") (NASDAQ: ENDP) today announced that the U.S. Food and Drug Administration (the "FDA") has requested a further stay of Endo's ongoing litigation against the FDA through March 15, 2019. 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, LLC ("Par"), manufacturers the only vasopressin product currently approved by the FDA, Vasostrict®. The suit was most recently stayed on January 7, 2019 for the duration of the government shutdown. 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 vasopre
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