UPDATE 1-Endo puts Vasostrict case against U.S. FDA on hold [Reuters]
Endo International plc - Ordinary Shares (ENDP)
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Source: Reuters
Endo puts Vasostrict case against U.S. FDA on hold | Reuters 2 Min Read (Reuters) - Endo International Plc on Monday said it would stay its lawsuit against the U.S. Food And Drug Administration until the end of the year after the FDA made new commitments on the regulation surrounding the active ingredient in its blood pressure medicine Vasostrict. Endo’s lawsuit, filed by its subsidiaries in a district court in Columbia last year, accused the agency of improperly authorizing the bulk compounding of hundreds of drugs, including “essentially a copy” of Vasostrict. Bulk compounding, whereby facilities are able to prepare tailored doses of drugs for individual patients, has become a widespread practice in the United States. Last month, the FDA proposed excluding three substances from a list of ingredients that could be used to manufacture compounded medications in bulk, including vasopressin, the active ingredient in Vasostrict. The action was the first time the health regulator pushed to
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