- Endo International (NASDAQ:ENDP) announces that it has agreed to extend a temporary stay of its litigation against the FDA.
- The litigation, filed in the U.S. District Court of Columbia in October 2017, seeks a declaration that FDA's "Interim Policy" on compounding using bulk drug substances under Section 503B of the Drug Quality and Security Act of 2013 amendments to the Federal Food, Drug, and Cosmetic Act is contrary to law.
- The litigation also seeks the immediate removal of vasopressin from FDA's Category 1 nominations list to assure that outsourcing facilities do not engage in bulk compounding of vasopressin-containing drug products under Section 503B.
- Based on the previous public statements from FDA, Endo previously agreed to FDA's request to stay the litigation until March 30. On March 23, FDA issued draft guidance describing the procedures that FDA intends to follow.
- As a result, Endo has agreed to extend the temporary litigation stay for an additional 180 days while FDA works toward implementation of the new compounding policy. Under the terms of the proposed stay, Endo will retain the ability to terminate the stay.
- Now read: Endo Pharmaceuticals: The Free Fall Continues
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