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Amneal’s Avastin-Referred Biosimilar Under FDA Review For Colorectal Cancer

Amneal's Avastin-Referred Biosimilar Under FDA Review For Colorectal Cancer

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The FDA has accepted for review Amneal Pharmaceuticals Inc’s (NYSE: AMRX) marketing application seeking approval for Bevacizumab, under Section 351(k) pathway of the Public Health Service Act. The covers for the treatment of metastatic colorectal cancer, in combination with IV fluorouracil-based chemotherapy for first- or second-line therapy and metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line Alymsys-containing regimen.

...read full article on Benzinga

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