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Alcohol-Free Docetaxel Injection Wins FDA Nod

Generic product developed in response to agency warning

The FDA has given the green light to docetaxel injection, nonalcohol formula (Eagle Pharmaceuticals), for the treatment of breast cancer, non–small-cell lung cancer, prostate cancer, gastric adenocarcinoma, and head-and-neck cancer.

Docetaxel, a taxane product, was originally developed by Sanofi and marketed as Taxotere. Since the drug’s patent expiration in 2011, several generic versions have entered the market. The alcohol content of these docetaxel formulations, including Taxotere, ranges from 2.0 g to 6.4 g in a 200-mg dose.

The need for an alcohol-free formulation of docetaxel arose in June 2014 when the FDA issued a drug safety communication warning patients that docetaxel may cause symptoms of alcohol intoxication after treatment. Manufacturers of docetaxel formulations for domestic use were subsequently required to revise their product labels to reflect alcohol content and include a drug safety warning. Some U.S. hospitals and clinics require patients to wait two or more hours after treatment with docetaxel before they can be released. The new alcohol-free formulation of docetaxel was developed to address these concerns.

Shipments of alcohol-free docetaxel are expected to begin in January 2016. The product will be available in 20 mg/1 mL, 80 mg/4 mL, and 160 mg/8 mL dosage forms.

Source: Eagle Pharmaceuticals; December 24, 2015.

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