A federal judge ruled the Food and Drug Administration correctly prevented a company from using an ingredient to make a compounded version of a medicine that is widely used by hospitals, a notable victory for drug makers that have been battling compounding pharmacies.
At issue was a dispute over whether a compounded form of vasopressin, which is used to increase blood pressure in patients with vasodilatory shock, filled a legitimate clinical need and, therefore, should be allowed to remain available alongside a brand-name version. The FDA tracks clinical need as part of its oversight of compounders that make and distribute large quantities of medicines.
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