FDA Approves Non-Alcohol Formula of Docetaxel Injection
Eagle Pharmaceuticals announced that the 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. This is the first alcohol-free formulation approved in the U.S.
The non-alcohol formulation was created to address concerns of a June 2014 FDA Drug Safety Communication that warned patients of symptoms of alcohol intoxication after treatment with docetaxel. Drug manufacturers were required to update their product labels to include the alcohol content and the new drug safety warning. Some hospitals and clinics required patients to wait ≥2 hours after treatment with docetaxel before they were discharged. The new formulation provides an option for those with alcohol sensitivity or those who prefer an alcohol-free treatment.
Docetaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions. It binds to free tubulin and promotes the assembly of tubulin into stable microtubules while simultaneously inhibiting their disassembly.
Docetaxel Injection, Non-Alcohol Formula will be available as a single pre-filled vial that does not require mixing in 3 strengths: 20mg/mL, 80mg/4mL, and 160mg/8mL. The product is expected to launch in January 2016.
For more information call (201) 326-5300 or visit EagleUS.com.