January 18, 2019 / 7:27 PM / 7 months ago

BRIEF-U.S. FDA Releases Label On Its Website For Samsung Bioepsis' Ontruzant

Jan 18 (Reuters) - U.S. Food and Drug Administration:

* U.S. FDA RELEASES LABEL ON ITS WEBSITE FOR SAMSUNG BIOEPSIS CO LTD’S ONTRUZANT

* U.S. FDA - ONTRUZANT IS A HER2/NEU RECEPTOR ANTAGONIST INDICATED FOR THE TREATMENT OF HER2-OVEREXPRESSING BREAST CANCER

* U.S. FDA - ONTRUZANT IS ALSO INDICATED FOR TREATMENT OF HER2-OVEREXPRESSING METASTATIC GASTRIC/GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA

* U.S. FDA - ONTRUZANT (TRASTUZUMAB-DTTB) IS BIOSIMILAR TO HERCEPTIN (TRASTUZUMAB)

* U.S. FDA - WARNS THAT ONTRUZANT, TRASTUZUMAB PRODUCTS CAN RESULT IN CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, & PULMONARY TOXICITY Source text: (bit.ly/2TUc3zk) Further company coverage:

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