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CHADDS FORD, Pa. — The Food and Drug Administration declined to approve Endo Pharmaceuticals’ regulatory application for a painkiller designed to thwart drug abusers, Endo said Friday.
The drug maker announced that the FDA had given it a complete response letter for its application for a crush-resistant formulation of Opana ER (oxymorphone hydrochloride). The company did not specify the reason for the letter, but said the agency had not requested additional clinical studies. A complete response letter means that the FDA has completed its review of a regulatory application, but questions remain that preclude final approval.
“As a result of ongoing discussions with the FDA, we have begun to address the issue from the complete response letter and will work closely with the agency to finalize our response,” Endo EVP research and development Ivan Gergel said.
Gergel said the company planned to respond to the FDA by mid-year and would expect the review to take six months.