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Teikoku gets FDA acknowledgment of receipt for Docetaxel Injection

Teikoku Pharma USA (TPU) has received an acknowledgment of the receipt from the US Food and Drug Administration (FDA) for a 505(b)(2) new drug application (NDA) for Docetaxel Injection Concentrate, Non-Alcohol Formula.

The Docetaxel injection is designed to treat breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer.

TPU executive VP and chief operating officer Paul Mori said: "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."

In June 2014, the FDA issued a drug safety warning about docetaxel formulations indicating 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 medications."

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

The company said that the existing docetaxel formulations, including the brand Taxotere, range in alcohol content from 2.0 to 6.4 grams in 200mg dose.

Currently, manufacturers of docetaxel formulations for use in the US have revised their product labels to reflect alcohol content and the drug safety warning.

The Docetaxel Injection Concentrate, Non-Alcohol formula comes as one vial docetaxel injection in three presentations 20mg/1ml, 80mg/4ml, and 160mg/8ml.