In October 2017, Endo Pharmaceutical first launched its lawsuit against the US Food and Drug Administration (FDA) relating to the bulk compounding of certain products under the Drug Quality and Security Act (DQSA) of 2013 as being illegal.
The company also sought the removal of the active pharmaceutical ingredient (API) of its Vasostrict (vasopressin) from the FDA’s Category 1 nominations list to prevent compounders from manufacturing the API.
Yesterday, Endo announced it had agreed with the FDA to voluntarily dismiss its initial lawsuit, after the agency ordered removal of compounded vasopressin from the market and a compounder, Athenex, withdrew its case seeking to invalidate this position.
“Endo congratulates the FDA on the successful and well-reasoned implementation of Section 503B of the DQSA, and was very pleased to assist in the subsequent defense of separate litigation regarding those actions,” said Matthew Maletta, chief legal officer of Endo.
The DQSA allowed for bulk compounding only if there was a ‘clinical need’ for a particular drug substance, a position that the FDA clarified in subsequent guidance, after the lawsuit was instigated by Endo. Once the guidance was finalized, compounders of vasopressin “could not satisfy the statutory ‘clinical need’ requirement,” Endo stated.
This led Athenex, alongside ‘two affiliated entities’, to begin a lawsuit against the FDA, which was subsequently won by the agency, alongside the Department of Justice and Endo.
Vasostrict is an antidiuretic hormone that is used to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.
In second-quarter results, Vasostrict brought in sales of $116m (€106m) globally, representing Endo’s highest earning product.