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Labopharm Inc. (DDSS) has received a complete response letter from the U.S. FDA for the new drug application (NDA) submission of its novel formulation of the antidepressant trazodone.
The letter indicates Labopharm's application cannot be approved in its present form due to deficiencies following an FDA inspection of the active pharmaceutical ingredient (API) manufacturing facility, which was completed July 3, 2009. The FDA letter states: "Satisfactory resolution of these deficiencies is required before this application may be approved." No efficacy or safety issues were raised.
"We intend to work closely with the FDA and Angelini to resolve these issues as rapidly as possible," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "We continue to prepare for the commercialization of our novel antidepressant and intend to launch in the U.S. market as soon as possible after we receive approval."
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