NOVARTIS PHARMS CORP N 37490Letterhttp://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022059Orig1s016,s017ltr.pdf02205901710/18/2013 12:00:00 AMSE8Efficacy Supplement with Clinical Data to Support 022059001TABLET;ORALEQ 250MG BASE11TYKERBLAPATINIB DITOSYLATE