Endo drops FDA compounding lawsuit

Oct. 1, 2019

Endo International announced that it has dropped its case against the U.S. FDA regarding the unlawful compounding of vasopressin from bulk drug substances.

In October 2017, after a site that produces bulk compounded medications began selling a drug Endo called “a copy” of its medication, Vasostric, Endo initiated a lawsuit against the FDA challenging the agency's interim policy authorizing the bulk compounding of drugs. Specifically, that policy allowed the allow bulk compounding of vasopressin, the active ingredient in Endo's Vasostrict. Endo claimed this policy was a violation of the Drug Quality and Security Act (DQSA), which only allows bulk compounding only if FDA determines there is a genuine "clinical need."

The agency then began taking steps to implement the requirements of the DQSA, and in particular issued proposed guidance regarding the statutory "clinical need" requirement. To allow FDA to create new regulations, Endo decided to delay its lawsuit on September 2018. 

When the FDA finalized its new guidance a few months ago, it also said that bulk compounders of vasopressin competing with Vasostrict could not satisfy the statutory "clinical need" requirement. in light of this determination, Endo has agreed with the Department of Justice and the FDA to voluntarily dismiss the lawsuit.

Read the press release