Endo announces FDA decision not to include vasopressin on 503B bulks list

Endo International announced that the U.S. Food and Drug Administration has determined that there is no clinical need to compound vasopressin under Section 503B of the Drug Quality and Security Act. As a result, it will be unlawful for outsourcing facilities to sell compounded vasopressin products unless they manufacture those products using an FDA-approved vasopressin product, rather than bulk vasopressin, or if vasopressin were to be added to the FDA’s drug shortage list. Par Sterile Products, a subsidiary of Endo, is the manufacturer of Vasostrict, the only vasopressin product approved by the FDA. Par and another Endo subsidiary are plaintiffs in a lawsuit against the FDA challenging a previously issued “interim policy” that authorized bulk compounding of vasopressin in violation of the applicable statute. “Endo is incredibly pleased that the FDA has correctly concluded that bulk compounding using vasopressin is inappropriate. We appreciate that the FDA is addressing the concerns which prompted our litigation by continuing its efforts to comply with the Drug Quality and Security Act, and we anticipate discussing with the FDA the impact of this decision on our pending litigation in the near future,” said Matthew Maletta, Executive Vice President and Chief Legal Officer of Endo.

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