Endo Pharmaceuticals today announced that it received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for its new formulation of OPANA® ER designed to be crush resistant. The complete response letter did not require that additional clinical studies be conducted for approval of the NDA.
"As a result of ongoing discussions with FDA, we have begun to address the issue from the complete response letter and will work closely with the agency to finalize our response," said Dr. Ivan Gergel, M.D., executive vice president, R&D, Endo Pharmaceuticals. "We are confident that we can address the issue set forth, currently anticipate responding to the FDA by mid 2011 and would expect a six month review cycle once our response is filed. We remain focused on bringing this new formulation of OPANA ER to market for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time."
Antibiotic resistance threatens millions of lives worldwide