Endo drops FDA lawsuit over compounding

30 September 2019

Ireland-headquartered drugmaker Endo International (Nasdaq: ENDP) has dropped a case against the US Food and Drug Administration (FDA).

The company had initially sued the FDA in October 2017, challenging its interim policy authorizing the bulk compounding of drugs, including Endo’s antidiuretic hormone Vasostrict (vasopressin).

Endo's lawsuit alleged that the FDA's interim policy violated Section 503B of the Drug Quality and Security Act (DQSA) and other provisions of the Federal Food, Drug, and Cosmetic Act which allow bulk compounding only if the FDA first makes a determination that there is a genuine ‘clinical need’ for compounding from a particular bulk drug substance.

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