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FDA postpones approval of Hanmi Pharmaceutical’s novel breast cancer treatment
FDA postpones approval of Hanmi Pharmaceutical’s novel breast cancer treatment
IndustryMar 2, 2021
South Korea’s Hanmi Pharmaceutical announced Tuesday that the US Food and Drug Administration has postponed its commercialization approval of Oraxol. Oraxol is an oral formulation of paclitaxel, a drug used to kill dividing tumor cells. The novel treatment for metastatic breast cancer currently outlicensed to the company’s US partner Athenex. In a statement released Tuesday, Hanmi said its US partner Athenex received a complete response letter, in which the FDA included a review