Cymbalta duloxetine regulatory update

Eli Lilly disclosed in its earnings that the PDUFA date for an sNDA for Cymbalta duloxetine to treat chronic pain passed without FDA action. Based on discussions with agency, Eli Lilly said it expects that the agency will schedule an advisory committee meeting to discuss the application next half. FDA previously cancelled a Jan. 28 meeting of its Anesthetic and Life Support Drugs Advisory Committee to discuss the application to allow time to review new clinical data submitted by Eli Lilly related to the product's benefit-risk profile for the indication. ...