Eagle Pharma And Teikoku Pharma Won FDA Approval of Docetaxel Injection, First and Only Alcohol-Free Formulation

Eagle Pharmaceuticals, Inc. (“Eagle” or “the Company”) announced that the U.S. Food and Drug Administration (“FDA”) has approved Docetaxel Injection, Non-Alcohol Formula for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer. Eagle entered into an exclusive licensing agreement with Teikoku Pharma USA Inc. in October 2015 to market, sell and distribute Docetaxel Injection in the U.S.

Docetaxel Injection is the first alcohol-free formulation approved in the U.S.  It presents as one, pre-filled vial that does not require mixing and is available in three different dosages: 20mg/1ml, 80mg/4mL, and 160mg/8mL; and 24 hours of stability at final dilution strength.

The need for an alcohol-free docetaxel gained visibility 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. This formulation of docetaxel was specifically developed to address these concerns.

Docetaxel is a taxane product indicated for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer.

Docetaxel was originally developed by Sanofi and marketed under the Taxotere® brand. Since its patent expiration in 2011, several generics entered the market. The alcohol content of these docetaxel formulations, including Taxotere, ranges from 2.0 to 6.4 grams in a 200 mg dose.