August 25, 2009 / 9:04 PM / 8 years ago

UPDATE 2-FDA could rule on Labopharm drug in February

* FDA accepts latest filing on trazodone formulation

* Labopharm says decision on drug could come in Feb

* Shares jump more than 20 pct in after-hours trade (Adds details, stock price; in U.S. dollars unless noted)

By Wojtek Dabrowski

TORONTO, Aug 25 (Reuters) - Canadian drugmaker Labopharm Inc DDS.TO said on Tuesday that U.S. regulators have accepted its latest filing regarding the antidepressant trazodone and that a decision on the drug could come in February.

The company's shares raced about 23 percent higher to $2.00 in after-hours electronic trading, following the announcement, from their regular-session close of $1.62 on Nasdaq.

Labopharm said the U.S. Food and Drug Administration has accepted its filing regarding the novel formulation of trazodone as complete and designated it as a Class 2 resubmission.

"The FDA has assigned Labopharm a new Prescription Drug User Fee Act (PDUFA) action date of February 11, 2010," the company said in a statement.

Tuesday's announcement came after Labopharm Chief Executive James Howard-Tripp told Reuters last month that he expected trazodone to launch in the United States early next year, despite the FDA's earlier decision not to approve it.

In July, the FDA told Labopharm its new drug application for the antidepressant couldn't be approved because of "deficiencies following the FDA's inspection of the manufacturing facility of the active pharmaceutical ingredient supplier."

The supplier submitted an action plan to address the deficiencies on July 24.

The antidepressant could be crucial for the small Montreal-based drugmaker. The company estimates it could generate as much as $500 million a year in sales and is seeking a U.S. marketing partner for the product.

"Labopharm continues to prepare for the commercialization of its novel antidepressant and, pending FDA approval, intends to launch in the U.S. shortly thereafter," it said.

Labopharm shares closed 5 Canadian cents lower at C$1.75 on the Toronto Stock Exchange.

$1=$1.09 Canadian Reporting by Wojtek Dabrowski; editing by Rob Wilson

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