Labopharm Inc. is trading on strong volume this morning after receiving a much anticipated letter from the FDA stating that  Angelini has appropriately addressed all deficiencies cited by the FDA following after the the manufacturing facility had been inspected in June and July this year. The Angelini’s manufacturing facility has been classified as acceptable.

The stock is trading 1.84 Up 0.48 (35.29%) on that news as this written.

Labopharm Inc. (DDSS) today announced that it has been informed by Angelini, the manufacturer of the active pharmaceutical ingredient (API) for the Company’s novel trazodone formulation, that it has received a letter from the U.S. Food and Drug Administration (FDA) stating that Angelini has appropriately addressed all deficiencies cited by the FDA following its inspection of the manufacturing facility in June and July of this year. The letter further states that Angelini’s manufacturing facility has been classified as acceptable.

Labopharm received a complete response letter from the FDA on July 17, 2009 indicating the Company’s new drug application (NDA) for its novel trazodone formulation could not be approved in its present form due to the deficiencies at the API supplier’s manufacturing facility. The letter did not raise any efficacy or safety issues.

Labopharm’s novel formulation of trazodone is currently under regulatory review in the U.S. with an action date under the Prescription Drug Users Fee Act (PDUFA) of February 11, 2010.

About Labopharm Inc.

Labopharm Inc., a specialty pharmaceutical company, develops drugs by incorporating its proprietary controlled-release technologies. It offers once-daily formulation of the analgesic tramadol under the RYZOLT brand name for the treatment of severe chronic pain in adults. The company sells RYZOLT primarily in the United States, Europe, Canada, South Korea, and Australia. Labopharm’s products in pipeline include once-daily formulation of trazodone, a serotonin antagonist reuptake inhibitor for the treatment of depressive disorder. Its product candidates in clinical development based on Contramid platform comprise twice-daily formulation of tramadol plus acetaminophen to address acute pain; and Abuse Deterrent Platform to provide safer medications through resistance to the uncontrolled release of the active ingredient after actions, such as breaking, chewing, crushing and heating, or consumption with alcohol. Its product candidates in clinical development based on the Polymeric Nano-Delivery System platform comprise lipid-and preservative-free formulation of the intravenous anaesthetic agent propofol; and SN-38, which is the active metabolite in the prescribed intravenous colon cancer drug irinotecan. Labopharm was formerly known as Centre de recherche appliquee pharmaceutique CRAP inc. and changed its name to Labopharm Inc. in September 1994. The company was founded in 1990 and is headquartered in Laval, Canada.