Non-Alcohol Formula of Docetaxel Injection Submitted for FDA Review
Teikoku Pharma USA announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for Docetaxel Injection Concentrate, Non-Alcohol Formula for the treatment of breast cancer, non-small cell lung cancer (NSCLC), prostate cancer, gastric adenocarcinoma, and head and neck cancer.
Previously on June 20, 2014, the FDA had issued a drug safety warning about docetaxel formulations. This communication indicated that docetaxel formulations, which contain alcohol, might cause patients to experience intoxication during and after treatment.
The current available docetaxel formulations, including Taxotere range in alcohol content from 2–6.4g in a 200mg dose. Currently manufacturers of docetaxel formulations for use in the U.S. have revised their product labels to reflect alcohol content and the drug safety warning.
Docetaxel Injection Concentrate, Non-Alcohol formula will be available in a vial as 20mg/1mL, 80mg/4mL, and 160mg/8mL strengths.
For more information visit TeikokuUSA.com.