FDA approves injection concentrate formulation for docetaxel
The FDA has approved a new one-vial formulation of the chemotherapeutic agent docetaxel (Taxotere Injection Concentrate).
The FDA has approved a new one-vial formulation of the chemotherapeutic agent docetaxel (Taxotere Injection Concentrate).
The agent is anticipated to become available nationwide in the fall in both 80-mg and 20-mg dosages.
Previously, docetaxel was available in a two-vial formulation-one vial containing docetaxel concentrate and the other with the diluent. The single vial eliminates the need for the initial dilution step with the diluent. Now at 20 mg/mL concentration, it is ready to be added directly into the infusion solution.
With one-vial docetaxel, the pharmaceutical ingredients and the 1-hour intravenous infusion administration to the patient remain the same.
Docetaxel is approved by the FDA for use in treating five types of cancer, including metastatic androgen-independent prostate cancer.
