Regulatory Affairs

Endo receives subpoena from US Attorney Office on products featuring oxymorphone

Published 12 January 2018

Endo International's subsidiary Endo Pharmaceuticals has received a grand jury subpoena from the US Attorney's Office for the Southern District of Florida seeking documents and information relating to products containing oxymorphone.

The subpoena broadly requests documents including, among others, those produced in past or pending lawsuits and those relating to product safety and efficacy, overdoses, diversion, thefts, overprescribing, abuse/misuse, dependency or tolerance, withdrawal, addictiveness, adverse events and manipulation. 

The subpoena also requests distribution and other third party agreements, together with sales and marketing, training, financial, compensation and corporate information, as well as documents relating to interactions with various government agencies, including the U.S. Food and Drug Administration, Drug Enforcement Administration, Veterans Administration, Federal Trade Commission, Department of Health & Human Services, Medicare and Medicaid. 

Endo and EPI intend to be responsive to the subpoena and cooperate with any related government investigation.

In all circumstances, it is Endo's policy to comply with applicable laws, rules, regulations and industry guidance governing the sale and marketing of pharmaceutical products.

Endo International is a highly focused generics and specialty branded pharmaceutical company delivering quality medicines to patients in need through excellence in development, manufacturing and commercialization.

Source: Company Press Release