Endo receives FDA Complete Response Letter on AVEED NDA.
M2 EUROPHARMA-(C)1999-2009 M2 COMMUNICATIONS
3 December 2009 - US-based specialty pharmaceutical company Endo Pharmaceuticals (NASDAQ: ENDP) said today it has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for its extended-duration testosterone undecanoate injection, AVEED, for men diagnosed with low testosterone (hypogonadism).
In the CRL, the FDA has requested information from the company 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 (REMS) is not sufficient.
Endo said that it is currently evaluating the CRL.
Known as Nebido outside the United States, AVEED was licensed from Bayer Schering Pharma AG, Germany to Indevus Pharmaceuticals, a company Endo acquired earlier this year. Nebido, discovered and developed by Bayer Schering Pharma, has subsequently been approved in 86 countries worldwide and is available in more than 50 countries across Europe, Asia Pacific and Latin America.