Biotech Values

[biocqr]

EGRX > Eagle Pharmaceuticals Announces FDA Approval of Docetaxel Injection, Non-Alcohol Formula

http://finance.yahoo.com/news/eagle-pharmaceuticals-announces-fda-approval-115000530.html

Eagle Pharmaceuticals, Inc. (“Eagle” or “the Company”) (Nasdaq:EGRX) announced today that the U.S. Food and Drug Administration (“FDA”) 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.

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.

The need for an alcohol-free docetaxel gained visibility in June 2014 when the FDA issued a Drug Safety Communication warning patients that docetaxel may cause symptoms of alcohol intoxication after treatment. Manufacturers of docetaxel formulations for domestic use were subsequently required to revise their product labels to reflect alcohol content and include a drug safety warning. Some U.S. hospitals and clinics require patients to wait two or more hours after treatment with docetaxel before they can be released. This formulation of docetaxel was specifically developed to address these concerns.