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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June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.