FDA Accepts Labopharm’s Response On Trazodone

The FDA has accepted Labopharm’s response regarding its novel formulation of the antidepressant – trazodone as complete, and designated it as a Class 2 resubmission.

Labopharm has 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.

The company said that the novel trazodone formulation could not be approved in its present form due to deficiencies following the FDA’s inspection of the manufacturing facility of the active pharmaceutical ingredient (API) supplier – Angelini.

Moreover, the letter did not raise any efficacy or safety issues. Angelini submitted an action plan addressing the deficiencies to the FDA on July 24, 2009.