Biotech Values

[DewDiligence]

This Seroquel case was the subject of a AZN Citizen Petition recently rejected by the FDA. AZN is trying to press essentially the same argument that failed for BMY in the Glucophage litigation a decade ago: that a generic drug shouldn’t be approved by the FDA unless the generic’s label exactly matches the label of the branded drug (http://www.cptech.org/ip/health/gluco.html ). That litigation involved the pediatric-extension labeling for Glucophage, which is not an issue in the Seroquel suit, but the two cases are conceptually similar.