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 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.