Second "complete response" letter for Nebido leaves U.S. path unclear
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA sent Endo Pharmaceuticals a "complete response" letter for its NDA for Nebido (to be known commercially as Aveed in the U.S.) on Dec. 3, requesting further info on the potential for serious adverse events. An oil-based depot injection of testosterone for men hypogonadism, Nebido has been linked to reports of post-injection anaphylaxis and pulmonary oil microembolism. FDA also said Endo's proposed Risk Evaluation and Mitigation Strategy is insufficient. Although Nebido has been approved in 86 countries and marketed in more than 50 nations in Europe, Asia Pacific and Latin America, this is the second "complete response" letter from FDA. Indevus Pharmaceuticals, which Endo acquired earlier this year, received a "complete response" to the initial NDA in June 2008, seeking further study of potential adverse events including coughing episodes and difficulty breathing (1"The Pink Sheet" DAILY, June 4, 2008). In a Dec. 4 note, Lazard Capital analyst William Tanner suggested the latest letter might send Endo back to square one. "It appears that the safety questions raised in the first CR letter remain unanswered although this latest re-submission included data from more than 14,000 injections in 2,600 patients," he wrote
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