Endo puts Vasostrict case against U.S. FDA on hold

[September 24, 2018]  (Reuters) - Endo International Plc on Monday said it would stay its lawsuit against the U.S. Food And Drug Administration until the end of the year after the FDA made new commitments on the regulation surrounding the active ingredient in its blood pressure medicine Vasostrict.

Endo's lawsuit, filed by its subsidiaries in a district court in Columbia last year, accused the agency of improperly authorizing the bulk compounding of hundreds of drugs, including "essentially a copy" of Vasostrict.

Bulk compounding, whereby facilities are able to prepare tailored doses of drugs for individual patients, has become a widespread practice in the United States.

Last month, the FDA proposed excluding three substances from a list of ingredients that could be used to manufacture compounded medications in bulk, including vasopressin, the active ingredient in Vasostrict.

The action was the first time the health regulator pushed to exclude any substance that may be used to bulk-produce compounded drugs that do not need to go through its safety approval process.

"We believe that a brief additional stay of our litigation is appropriate to allow FDA to complete its rulemaking process," Matthew Maletta, Endo's chief legal officer, said in a statement on Monday.

If the court approves the proposed stay, the hearing scheduled for October 3, 2018 will be taken off calendar, the company said.

Endo previously agreed to stay requests from the FDA in January 2018 and April 2018.

(Reporting by Tamara Mathias in Bengaluru; editing by Shailesh Kuber and Patrick Graham)

[© 2018 Thomson Reuters. All rights reserved.]

Copyright 2018 Reuters. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.  Thompson Reuters is solely responsible for this content.