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FDA Approves Generic Docetaxel

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This week Hospira, Inc (Lake Forest, Ill) announced approval by the US Food and Drug Administration for docetaxel, a generic form of Sanofi Aventis’s drug Taxotere. The drug is already available in Europe and Australia and will be the first generic version available in the United States.
 
Docetaxel has been approved to treat a variety of cancers including breast and lung cancers. Unlike the original product, which required a two-step preparation method, Hospira’s version will come in a single-vial formulation. According to Thomas Moore, president, US Hospira, this new formulation will offer a “differentiated delivery system designed to enhance caregiver safety.”
 
The product, slated to launch later this month, will be available in 20 mg, 80 mg, and 160 mg vials at the original 10 mg/mL concentration.

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