Endo Pharmaceuticals (ENDP) Receives Complete Response From FDA On FORTESTA
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Endo Pharmaceuticals (Nasdaq: ENDP) received a Complete Response letter from the FDA regarding the New Drug Application for FORTESTA 2% Gel for men diagnosed with low testosterone (Low T), also known as hypogonadism.
"The potential of this action was considered in the structure of the deal to in-license this product," said Dr. Ivan Gergel, M.D., executive vice president, R&D, Endo Pharmaceuticals. "We will continue to work closely with the FDA to address their questions and we expect to file a complete response, mid-2010. Endo is committed to bringing FORTESTA to market to offer men another option for testosterone replacement therapy."
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