FDA Approved First Generic Docetaxel

April 2011, Vol 2, No 2 - FDA Approvals, News & Updates


The US Food and Drug Administration (FDA) approved docetaxel injection (Hospira)—the first generic formulation of Taxotere (sanofi-aventis). Generic docetaxel is already available in Europe and Australia. Docetaxel, an antineoplastic chemotherapy medication, is indicated for the treatment of several cancers at different stages, including metastatic and adjuvant breast cancer; metastatic androgen-independent prostate cancer; advanced non–small-cell lung cancer; advanced gastric adenocarcinoma; and locally advanced squamous-cell carcinoma of the head and neck. Unlike the original brand-name drug, which requires a 2-step preparation method, the new generic formulation comes in a single-vial formulation. According to Thomas Moore, Hospira president, in addition to the potential cost-savings, another valuable feature of the generic formulation is its “differentiated delivery system, designed to enhance caregiver safety.” Docetaxel will be available in 20-mg, 80-mg, and 160-mg vials at the original 10-mg/mL concentration. (March 9, 2011)