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.

RELATED: Chemotherapy Drug May Cause Alcohol Intoxication

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.

Loading links....