Monday, Endo Pharmaceuticals Holdings Inc. (ENDP) said it received a complete response letter from the U.S. Food and Drug Administration or FDA regarding the New Drug Application or NDA for FORTESTA 2% Gel for men diagnosed with low testosterone or Low T, also known as hypogonadism.
"The potential of this action was considered in the structure of the deal to in-license this product. 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," said Ivan Gergel, M.D., executive vice president, R&D, Endo Pharmaceuticals.
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