Labopharm: FDA Clears Supplier’s Plant

NEW YORK (AP) -- The company that makes the active ingredient in Labopharm Inc.'s version of the antidepressant trazodone has fixed manufacturing issues that delayed approval for the drug, Labopharm said.

The Canadian drugmaker said Wednesday Angelini, the ingredient maker, received a letter from the Food and Drug Administration that said problems with the manufacturing facility have been addressed. The facility is now acceptable, Labopharm said.

Labopharm is developing a once-per-day version of trazodone, which is normally given twice per day. In July, the FDA said it could not approve the drug because of problems with Angelini's manufacturing facility. The agency is expected to make a decision by Feb. 11, 2010.

The announcement appeared to improve Labopharm's chances to gain regulatory approval for its drug, and in afternoon trading its stock climbed 45 cents, or 33 percent, to $1.81.

More in Operations