September 4, 2018 / 10:28 PM / in 2 months

FDA fights lawsuit by Endo challenging drug-compounding policy

The U.S. Food and Drug Administration has urged a federal judge to reject Endo International PLC’s challenge to how it regulates drug compounding, saying the lawsuit incorrectly targets an interim rather than final policy.

The FDA in papers filed on Friday in federal court in Washington, D.C. opposed Endo’s bid to block a policy the agency adopted in 2015 that governs what substances large drug compounders can use to make medications.

To read the full story on WestlawNext Practitioner Insights, click here: bit.ly/2NONUY8

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