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Docetaxel Non-Alcohol Formula FDA Approval History

FDA Approved: Yes (First approved December 22, 2015)
Brand name: Docetaxel Non-Alcohol Formula
Dosage form: Injection
Company: Eagle Pharmaceuticals, Inc.
Treatment for: Breast Cancer, Non-Small Cell Lung Cancer, Prostate Cancer, Gastric Cancer, Head and Neck Cancer

Docetaxel Injection, Non-Alcohol Formula is an alcohol-free formulation of docetaxel for use in the treatment of patients with breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer.

The approval of a non-alcohol formula follows a warning from the U.S. Food and Drug Administration (FDA) advising patients and healthcare professionals that intravenous docetaxel formulations (Taxotere, Docefrez and generics) contain ethanol (alcohol), which may cause patients to experience intoxication or feel drunk during and after treatment.

Development timeline for Docetaxel Non-Alcohol Formula

Dec 28, 2015Approval Teikoku Pharma USA, Inc. Announces FDA Approval of Docetaxel Injection, Non-Alcohol Formula

Further information

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