According to Drugs@FDA, Xultophy label was updated to expand the indication for use in patients uncontrolled on OADs. Additionally, the new label also included 3 other major changes: 1) recommended starting dose, 2)  clinical data from DUAL I, DUAL IV trials and 3) a caution for audible clicks. Of note, Novo did not issue a press release on this FDA approval. Below, FENIX provides an analysis of the updated Xultophy label and its impact on the injectable market segment.