
[Federal Register Volume 78, Number 65 (Thursday, April 4, 2013)]
[Notices]
[Pages 20327-20328]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07843]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]


Joint Meeting of the Advisory Committee for Reproductive Health 
Drugs and the Drug Safety and Risk Management Advisory Committee; 
Amendment of Notice

AGENCY:  Food and Drug Administration, HHS.

ACTION: Notice.

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    The Food and Drug Administration (FDA) is announcing an amendment 
to the notice of the joint meeting of the Advisory Committee for 
Reproductive Health Drugs and the Drug Safety and Risk Management 
Advisory Committee. This meeting was announced in the Federal Register 
of March 14, 2013 (78 FR 16271-16272). The amendment is being made to 
reflect a change in the Agenda portion of the document. There are no 
other changes.

FOR FURTHER INFORMATION CONTACT:  Kalyani Bhatt, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31 rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, FAX: 301-847-8533, ACRHD@fda.hhs.gov, or use the FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington DC area), and follow the prompts to the desired center or 
product area. Please call the Information Line for up-to-date 
information on this meeting.

SUPPLEMENTARY INFORMATION:  In the Federal Register of March 14, 2013, 
FDA announced that a joint meeting of the Advisory Committee for 
Reproductive Health Drugs and the Drug Safety and Risk Management 
Advisory Committee would be held on April 18, 2013. On page 16272, in 
the first column, the Agenda portion of the document is changed to read 
as follows:
    Agenda: The committee will discuss the efficacy and safety of new 
drug application (NDA) 22219, AVEED (testosterone undecanoate) 
intramuscular injection, submitted by Endo Pharmaceutical Solutions, 
Inc., for the proposed indication of replacement

[[Page 20328]]

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. In addition to AVEED, other approved 
testosterone injectable products will be referenced, especially in 
regard to oil microembolism and potential anaphylactic reactions 
reported for those products.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: March 27, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-07843 Filed 4-3-13; 8:45 am]
BILLING CODE 4160-01-P


