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Panels to Discuss Endo NDA for Testosterone Deficiency

03/14/2013

Federal Register Notice: FDA’s Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee will meet 4/18, from 8 a.m. to 5 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committees will discuss the efficacy and safety of Endo Pharmaceutical Solutions’ NDA for Aveed (testosterone undecanoate) intramuscular injection for the proposed indication of replacement therapy in adult males for conditions associated with a deficiency or absence of testosterone. The safety discussion will focus on postmarketing reports of oil embolism in the lungs and potential anaphylactic reactions and will include other approved testosterone injectable products. Contact Kalyani Bhatt, 301-796-9001. To view this notice, click here.

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