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.
Last year, the FDA determined no such need existed, since the brand-name version, which is called Vasostrict, was adequately serving patients. So the agency excluded the bulk substance, or ingredient, from a list that could be used to make a compounded version. The move came after Endo International (ENDP) and its Par Sterile Products unit sued the FDA for improperly allowing bulk compounding of hundreds of drugs.
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