Teikoku Pharma USA Announces New Drug Application to The U.S. Food and Drug Administration for Docetaxel Injection Concentrate, Non-Alcohol Formula
San Jose, Calif., Teikoku Pharma USA (TPU) announced today that it has submitted a 505(b)(2) New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Docetaxel Injection Concentrate, Non-Alcohol Formula on February 26, 2015 and received an acknowledgment of the receipt from FDA. Docetaxel Injection Concentrate, Non-Alcohol Formula is for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer.
“Docetaxel Injection Concentrate, Non-Alcohol Formula offers an alternative to patients who might experience an adverse reaction to currently marketed docetaxel formulations due to alcohol sensitivity and those who simply prefer an alcohol free product.” said Paul Mori, Executive VP and Chief Operating Officer at TPU.
The Need for a Non-Alcohol Formula
On June 20 2014, the FDA issued a drug safety warning about docetaxel formulations. This communication indicated that docetaxel formulations, which contain alcohol, might cause patients to experience intoxication during and after treatment. 1 According to this communication, the FDA warned:
“Health care professionals should consider the alcohol content of docetaxel when prescribing or administering the drug to patients, particularly in those whom alcohol intake should be avoided or minimized and when using it in conjunction with other medications” 1
“Consider a docetaxel formulation with the lowest possible alcohol content for patients who experience adverse reactions.” 1
The current available docetaxel formulations, including the brand Taxotere®, range in alcohol content from 2.0 to 6.4 grams in 200 mg dose. At present, manufactures of docetaxel formulations for use in the United States have revised their product labels to reflect alcohol content and the drug safety warning.
Docetaxel is a taxane product indicated for breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer.2
TPU’s Docetaxel Injection Concentrate, Non-Alcohol Formula
TPU’s Docetaxel Injection Concentrate, Non-Alcohol formula comes as one vial docetaxel injection in three presentations: 20mg/1ml, 80mg/4mL, and 160mg/8mL.
Our mission is to improve the quality of life of patients around the world by providing new benefits for unmet patient needs. added Paul Mori.
About Teikoku Pharma USA
Teikoku Pharma USA Inc. (“TPU”), a wholly owned subsidiary of Teikoku Seiyaku Co., Ltd. of Japan, is an international specialty pharmaceutical company that develops and manufactures pharmaceutical products based on our delivery platform technologies.
TPU is the NDA holder of LIDODERM® (Lidocaine 5% Patch) for post herpetic neuralgia (PHN) and is distributed by Endo Pharmaceuticals in the US, is licensed to Grünenthal GmbH mainly in Europe, South America and Oceania, and is distributed by other partners in Asia.
Teikoku’s therapeutic focus is addressing unmet medical needs in the pain management, central nervous system, and oncology categories.
For more information please contact: Francisco Bejar
- U.S. Food and Drug Administration. Drug Safety Communications. FDA warns that cancer drug docetaxel may cause symptoms of alcohol intoxication after treatment. June 20, 2014. Accessed: February 20, 2015.
- Docetaxel Package Insert. Sanofi-Aventis U.S. LLC. Bridgewater, NJ.Revised: 11/2014. Accessed: February 20, 2015.