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Endo Pharmaceuticals receives FDA complete response letter for AVEED NDA

Published on December 3, 2009 at 9:24 AM · No Comments

Endo Pharmaceuticals (Nasdaq: ENDP) today announced that it received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for its extended-duration testosterone undecanoate injection, AVEED(TM), 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 (REMS) is not sufficient.

Endo is currently evaluating the FDA's complete response letter.

SOURCE Endo Pharmaceuticals

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Posted in: Men's Health News | Pharmaceutical News

Tags: Anti-Inflammatory, Cancer, Carcinoma, Cardiovascular Disease, Diabetes, Endocrinology, Erectile Dysfunction, Hormone, Metabolic Syndrome, Migraine, Neuralgia, Neurology, New Drug Application, Oncology, Osteoarthritis, Prostate Cancer, Puberty, Testosterone, Urology, Voltaren

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