Eagle Pharmaceuticals, Inc., a specialty pharmaceutical company, announced that the US 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 US.

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

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 US 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 injection addresses a compelling need in the docetaxel market. As the first alcohol-free formulation approved in the US, we believe the benefits of this novel formulation will provide an option for patients with alcohol sensitivity or a preference for an alcohol-free treatment. We are excited to add alcohol-free docetaxel to our growing portfolio of differentiated injectable products and believe it has the potential to improve the lives of patients, resolve concerns among health care professionals at hospitals and infusion centers, and ultimately drive value for Eagle stakeholders,” said Scott Tarriff, president and chief executive officer of Eagle Pharmaceuticals.

Eagle expects to begin shipping docetaxel injection in January 2016. Eagle estimates that annual sales of generic docetaxel are approximately $75 million.