Endo Lifts Temporary Stay of FDA Litigation Following the Launch of a Bulk-Compounded Vasopressin Product by a Section 503B Outsourcing Facility
Endo International plc - Ordinary Shares (ENDP)
Last endo international plc - ordinary shares earnings: 2/26 06:00 am
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Source: PR Newswire
DUBLIN, Aug. 15, 2018 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) today announced that it is lifting a temporary stay of its litigation against the U.S. Food and Drug Administration (FDA). The litigation, filed in the U.S. District Court for the District of Columbia in October 2017 by the Company's subsidiaries, Par Sterile Products, LLC and Endo Par Innovation Company, LLC (collectively, "Endo"), 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 (DQSA) amendments to the Federal Food, Drug, and Cosmetic Act (FDCA) 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
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