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.

Unlock this article by subscribing to STAT Plus. To get you started, enjoy 50% off your first 3 months!


What is it?

STAT Plus is STAT's premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.

What's included?

  • Daily reporting and analysis
  • The most comprehensive industry coverage from a powerhouse team of reporters
  • Subscriber-only newsletters
  • Daily newsletters to brief you on the most important industry news of the day
  • Online intelligence briefings
  • Frequent opportunities to engage with veteran beat reporters and industry experts
  • Exclusive industry events
  • Premium access to subscriber-only networking events around the country
  • The best reporters in the industry
  • The most trusted and well-connected newsroom in the health care industry
  • And much more
  • Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr.

Leave a Comment

Please enter your name.
Please enter a comment.

Your daily dose of news in health and medicine

Privacy Policy