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