The Food and Drug Administration (FDA) has approved the Docetaxel Injection, Non-Alcohol Formula, from Teikoku Pharma USA to treat head and neck cancer as well as breast cancer, non-small-cell lung cancer, prostate cancer, and gastric adenocarcinoma.
Unlike other docetaxel formulations, the Docetaxel Injection is the first non-alcohol formulation approved in the United States. Also, it doesn’t require any prior dilution with a diluent and is ready to add to the infusion solution.
In June 2014, the FDA issued a Drug Safety Communication warning patients that docetaxel may cause symptoms of alcohol intoxication after treatment. Some hospitals and clinics require patients two wait 2 or more hours after docetaxel treatment before they can be released.
“We believe the benefits of this novel formulation will provide an option for patients with alcohol sensitivity or a preference for alcohol-free treatment,” said Scott Tarriff, president and chief executive officer of Eagle Pharmaceuticals.
The Docetaxel Injection is available in 20-mg/ml single-dose vials and in 80-mg/4-mL or 160-mg/8-mL multiple-dose vials. Teikoku Pharma USA is now in an exclusive license agreement with Eagle Pharmaceuticals to market, sell, and distribute the Docetaxel Injection in the United States, expected to begin in January.