Angelini Resolves Manufacturing Issue With FDA Regarding Trazodone

Angelini has received a letter from the FDA stating that it has appropriately addressed all deficiencies cited by the FDA, following its inspection of the manufacturing facility in June and July of this year.

Reportedly, the letter further states that Angelini’s manufacturing facility has been classified as acceptable.

Labopharm has received a complete response letter from the FDA on July 17, 2009 for the company’s NDA for trazodone formulation, that it could not be approved in its present form due to the deficiencies at the API supplier’s manufacturing facility.

The company, commenting on the complete response letter regarding novel trazodone formulation, said that the letter did not raise any efficacy or safety issues.

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