Labopharm's API Supplier Resolves OutstandingManufacturing Issues with the FDA
Wed, 10/07/2009 - 4:54am
Labopharm Inc. today announced that it has been informed by Angelini, themanufacturer of the active pharmaceutical ingredient (API) for the company'snovel trazodone formulation, that it has received a letter from the U.S. Foodand Drug Administration (FDA) stating that Angelini has appropriatelyaddressed all deficiencies cited by the FDA following its inspection of themanufacturing facility in June and July of this year. The letter furtherstates that Angelini's manufacturing facility has been classified asacceptable. Labopharm received a complete response letter from the FDA on July 17,2009 indicating the Company's new drug application (NDA) for its noveltrazodone formulation could not be approved in its present form due to thedeficiencies at the API supplier's manufacturing facility. The letter did notraise any efficacy or safety issues. Labopharm's novel formulation of trazodone is currently under regulatoryreview in the U.S. with an action date under the Prescription Drug Users FeeAct (PDUFA) of February 11, 2010.