Ireland-headquartered drugmaker Endo International (Nasdaq: ENDP) has applauded the US District Court for the District of Columbia's ruling supporting the Food and Drug Administration's (FDA) view that vasopressin cannot be used for compounding by outsourcing facilities.
The latest court decision follows an FDA decision in March not to list the antidiuretic hormone on the list of bulk drug substances permitted to be compounded under Section 503B of the Federal Food, Drug and Cosmetic Act.
Endo’s subsidiary Par Sterile Products is the manufacturer of Vasostrict, the only vasopressin product approved by the FDA.
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