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news.APP Pharmaceuticals is expected to begin marketing Anastrozole 1mg tablets in the US, following the FDA approval to Fresenius Kabi Oncology.
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APP Pharma and Fresenius Kabi Oncology Limited are members of the Fresenius Kabi Group of companies.
Anastrozole is therapeutically equivalent to the reference-listed drug Arimidex, which is currently marketed by AstraZeneca.
According to AstraZeneca, Arimidex is approved for the initial treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer and for the treatment of postmenopausal women with advanced breast cancer that has progressed following treatment with tamoxifen.
The patients with hormone receptor-negative disease and patients who did not previously respond to tamoxifen therapy rarely responded to Arimidex.
John Ducker, president and CEO of APP Pharma, said: “The approval of Anastrozole further expands APP Pharma’s product portfolio in the strategically important Oncology segment. We are delighted to be able to offer this important oral medication to new customers in the retail pharmacy channel.”