Novartis: Sandoz files biosimilar application with FDA
(CercleFinance.com) - Novartis' Sandoz on Wednesday said that US regulators have allowed it to resubmit a new biologics license application (BLA) for a proposed biosimilar of Amgen's pegfilgrastim.
Pegfilgrastim is prescribed to cancer patients undergoing chemotherapy to enhance the production of infection-fighting white blood cells, the generic pharmaceutical unit said.
Sandoz first received a letter of rejection, or "complete response letter," from the FDA in June 2016.
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Pegfilgrastim is prescribed to cancer patients undergoing chemotherapy to enhance the production of infection-fighting white blood cells, the generic pharmaceutical unit said.
Sandoz first received a letter of rejection, or "complete response letter," from the FDA in June 2016.
Copyright (c) 2019 CercleFinance.com. All rights reserved.