Thursday, Endo Pharmaceuticals Holdings Inc. (ENDP) said it has received a complete response letter from the U.S. Food and Drug Administration or FDA regarding the New Drug Application or NDA for its extended-duration testosterone undecanoate injection, AVEED, for men diagnosed with low testosterone. Low testosterone is also known as hypogonadism.
In the complete response letter, the FDA has requested information from Endo to address the agency's concerns regarding very rare but serious adverse events, including post-injection anaphylactic reaction and pulmonary oil microembolism. The letter also specified that the proposed Risk Evaluation and Mitigation Strategy or REMS is not sufficient, the company said.
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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.