TPU's submission of Docetaxel Injection Concentrate, Non-Alcohol Formula NDA acknowledged by FDA

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. 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 medication.s"

"Consider a docetaxel formulation with the lowest possible alcohol content for patients who experience adverse reactions."

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.


Teikoku Pharma USA Inc.


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