Federal Register Notice: FDA is amending the 3/14 notice of the 4/18 joint meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee to reflect a change of the word “embolism” to “microembolism” in the Agenda portion of the document. The committee 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 microembolism in the lungs and potential anaphylactic reactions. Contact Kalyani Bhatt, (301) 796-9001. To view this notice, click here.