12/20/2012 7:10:35 AM
CHADDS FORD, Pa., Dec. 19, 2012 /PRNewswire/ -- Endo Health Solutions Inc. (Nasdaq: ENDP) announced today that U.S. District Judge Reggie B. Walton, of the U.S. District Court for the District of Columbia, dismissed the case of Endo's subsidiary, Endo Pharmaceuticals Inc., against the U.S. Food and Drug Administration (FDA). Endo Pharmaceuticals argued that FDA failed to meet its legal obligation to determine in a timely manner whether the original formulation of OPANA ER was withdrawn from the market for reasons of safety. The judge ruled against Endo, noting that he believes the FDA has not unduly delayed making a determination on the matter. The FDA stated that it intends to make its determination by May 2013.
Endo reformulated OPANA ER to a version designed to be crush-resistant and launched this reformulated version in March 2012. The ruling by the court now allows for a generic non-tamper resistant version to enter the market on Jan. 2, 2013.
"We are extremely disappointed by today's decision," said Dave Holveck, president and chief executive officer of Endo Health Solutions. "Despite the fact that the generic product will not be therapeutically equivalent to the crush resistant formulation, the launch of a generic non-crush-resistant version of OPANA ER in January will irreparably undermine the significant progress made in the reduction of abuse and misuse of oxymorphone. We are hopeful that FDA will ultimately make the right decision before May in light of the surveillance data supporting that the original formulation of OPANA ER was discontinued for reasons of safety."
Endo Health Solutions Inc. (Endo) is a US-based diversified healthcare company that is redefining healthcare value by finding solutions for the unmet needs of patients along care pathways for pain management, pelvic health, urology, endocrinology and oncology. Through our operating companies: AMS, Endo Pharmaceuticals, HealthTronics and Qualitest, Endo is dedicated to improving care through a combination of branded products, generics, devices, technology and services that creates value for patients, providers and payers alike. Learn more at www.endo.com.
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SOURCE Endo Health Solutions Inc.