FDA OKs nonalcohol docetaxel for head/neck cancer

The U.S. Food and Drug Administration (FDA) has approved Teikoku Pharma USA's nonalcohol docetaxel injection for the treatment of head and neck cancer, breast cancer, non-small cell lung cancer, prostate cancer, and gastric adenocarcinoma.

The company's docetaxel injection is the first nonalcohol formulation approved in the U.S., according to Teikoku. It also requires no prior dilution and is ready to add to the infusion solution. It is available in three presentations: 20 mg/mL in single-dose vials and 80 mg/4 mL or 160 mg/8 mL in multiple-dose vials.

The need for nonalcohol docetaxel gathered steam in 2014 when the FDA warned patients that docetaxel may cause symptoms of alcohol intoxication after treatment. Makers of docetaxel formulations for domestic use were subsequently required to revise their product labels to warn about the risk. Some U.S. hospitals and clinics require patients to wait at least two hours after treatment with docetaxel before they can be released. Teikoku's formulation of docetaxel was specifically developed to address these concerns.

Teikoku entered a licensing agreement with Eagle Pharmaceuticals in 2015 to market, sell, and distribute the docetaxel injection in the U.S.

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