Eagle Pharmaceuticals Inc. (EGRX) announced that the U.S. Food and Drug Administration 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. Eagle entered into an exclusive licensing agreement with Teikoku Pharma USA Inc. in October 2015 to market, sell and distribute Docetaxel Injection in the U.S.
Eagle expects to begin shipping Docetaxel Injection in January 2016. Eagle estimates that annual sales of generic docetaxel are approximately $75 million.
Docetaxel Injection is the first alcohol-free formulation approved in the U.S.
Additional features of this product are: presents as one, pre-filled vial that does not require mixing; is available in three different dosages: 20mg/1ml, 80mg/4mL, and 160mg/8mL; and 24 hours of stability at final dilution strength.
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