The FDA accepted Exelixis’ supplemental new drug application of Cabometyx® for previously treated advanced Hepatocellular Carcinoma. The FDA approved Imdexxy developed by TherapeuticsMD for moderate to severe Dyspareunia
May 30, 2018
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The U.S. Food and Drug Administration (FDA) has accepted for filing Exelixis’ (EXEL) supplemental New Drug Application (sNDA) for Cabometyx® (cabozantinib) tablets for patients with previously treated advanced hepatocellular carcinoma (HCC). The FDA has determined that the application is sufficiently complete to permit a substantive review. The filing has been assigned a Prescription Drug User Fee Act (PDUFA) action date of January 14, 2019. Commenting on the news, Gisela Schwab, M.D., President, Product Development and …