Shares of Quebec-based Labopharm (TSX: DDS; Stock Forum) fell more than 13% to $2.06 Monday, as the company says the U.S. FDA will not approve its application for the antidepressant Trazodone in its present form as a result of deficiencies at a manufacturing facility.

The FDA’s comments follow its inspection of the active pharmaceutical ingredient manufacturing facility earlier this month, after which it said in a letter to the company that "satisfactory resolution of these deficiencies is required before this application may be approved." Labopharm says no efficacy or safety issues were raised.

Labopharm notes that the API manufacturer, Angelini, has said that the observations raised by the FDA are “not critical and that it has not been questioned about the continued supply of trazodone hydrochloride to the U.S. market.”

Angelini says it intends to address the observations raised by the FDA in an action plan that it will submit by July 24.

"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 CEO of Labopharm. "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," he added.

Labopharm submitted the new drug application for Trazodone in September 2008.

On the company’s Bullboard, tatvicjo said: “If problems with manufacturing are the only issue then clean up the process and we're off to the races. No efficacy or safety issues clears the path to market[sic].”

While Bleed noted: “Nothing is ever easy with the FDA. I see long delays because of this. Angelini is an Italian company. They close for the whole month of August...[sic]”

And, Bangkokboy replied: “…By reading the response it seems this is not a big issue like it was last time but needless to say we're stuck with another delay”…

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