> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Shutdown Causes Endo Litigation Delay
- URL: https://www.fdaweb.com/shutdown-causes-endo-litigation-delay/
- Published: 2019-01-03T12:00:00.000Z
- Updated: 2026-09-15T00:52:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143073

FDA has asked the DC federal court to continue a stay of Endo’s suit against the agency over bulk compounding of drugs including vasopressin until the government shutdown ends and agency and Justice Department employees are permitted to work again.

The suit previously was stayed until 12/31/18 and FDA had committed to use its best efforts to issue a final clinical need determination for vasopressin on or before that date. Endo had agreed to that stay and did not oppose the government’s motion to continue the stay for the time in which the government lacks appropriations.

The *Philadelphia Business Journal* [reports](https://www.bizjournals.com/philadelphia/news/2019/01/02/trump-shutdown-endo-fda-compound-vasostrict.html?ref=fdaweb.com) the company alleges that an FDA interim policy on bulk compounding under Section 503B of the Drug Quality and Security Act is unlawful because it authorized bulk compounding of drugs, including vasopressin, where the applicable legal requirements, including a determination of need, were not satisfied.

An Endo subsidiary, Par Sterile Products, manufactures Vasostrict, the only vasopressin product currently approved by FDA. It is indicated to treat septic shock.