NDA submitted 4/09 for a new strength of bupripion for MDD; Complete response letter received 2/10, requesting additional information; NDA amendment to be completed 2H2010
Brand N/A Generic CPI-300
Company name IntelGenx, Cary Pharmaceuticals Product type Non-speciality
Therapeutic category CNS Key uses Major Depressive Disorder (MDD)
Other Uses N/A Drug Class antidepressant
Dosage From oral, controlled-release Expected Approval 2011-Q2
FDA Filing 4/09 Last Update date March 01,2010
Link to pipeline report
Link to news article