Endo Pharmaceuticals (ENDP) Receives Complete Response From FDA On FORTESTA
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."
"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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