Cymbalta duloxetine regulatory update

FDA's Anesthetic and Life Support Drugs Advisory Committee will meet on Aug. 19 to discuss an sNDA from Eli Lilly for Cymbalta duloxetine to treat chronic pain. In April, Eli Lilly disclosed in its earnings that the PDUFA date for the sNDA had passed without FDA action. The agency previously cancelled a Jan. 28 panel meeting to allow time to review new clinical data submitted by Eli Lilly related to the product's benefit-risk profile (see BioCentury, April 26). ...