U.S. FDA advisory meetings through March 31

THIS DIARY IS FILED AS THE FOOD AND DRUG ADMINISTRATION
UPDATES ITS SCHEDULE. ALL ITEMS EST/GMT UNTIL MARCH 13 WHEN
TIMES ARE EDT/GMT.

For more information on the FDA’s Advisory Committee
meetings, see:
http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm
(Adds March 10 anesthetic drugs meeting)

TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE

DATE: Jan. 10 and 11, 0800/1300

LOCATION: FDA White Oak Conference Center, Building 31,
10903 New Hampshire Ave., Silver Spring, Md.

CONTACT: Caryn Cohen, 1-877-287-1373 (choose 2, Option 4)

The committee will continue to receive updates from the
Menthol Report Subcommittee and receive and discuss
presentations regarding the data requested by the committee at
the March meeting of the Tobacco Products Scientific Advisory
Committee.

GASTROINTESTINAL DRUGS ADVISORY COMMITTEE

DATE: Jan. 12, 0800/1300

LOCATION: FDA White Oak Campus, 10903 New Hampshire Avenue,
Building 31, the Great Room, White Oak Conference Center (room
1503), Silver Spring, Md.

CONTACT: Kristine Khuc, 301-796-9001

The committee will discuss the safety and efficacy of Eli
Lilly and Co’s (LLY.N: ) proposed drug Solpura, or liprotamase,
to treat exocrine pancreatic insufficiency due to cystic
fibrosis, chronic pancreatitis, surgical removal of all or part
of the pancreas known as pancreatectomy, or other conditions
that may curb function of the pancreas, which helps digest
food. Lilly acquired the drug with its acquisition of privately
held Alnara Pharmaceuticals Inc earlier this year.

PERIPHERAL AND CENTRAL NERVOUS SYSTEM DRUGS ADVISORY
COMMITTEE

DATE: Jan. 20-21, 0800/1300

LOCATION: FDA White Oak Campus, Building 31, 10903 New
Hampshire Ave., Silver Spring, Md.

CONTACT: Diem-Kieu Ngo, 301-796-9001

On Jan. 20, the committee will discuss a new drug
application for florbetapir F 18 injection, sponsored by
privately held Avid Radiopharmaceuticals Inc, proposed for use
in positron emission tomography (PET) imaging of beta-amyloid
aggregates in the brain to help rule out Alzheimer’s disease.
Eli Lilly has announced plans to acquire Avid
Radiopharmaceuticals.

On Jan. 21, the committee will discuss a new drug
application for Bayer AG’s (BAYGn.DE: ) gadobutrol injection,
proposed for use in diagnostic magnetic resonance imaging (MRI)
in adults and children 2 years of age and older to detect and
visualize areas with disrupted blood brain barrier (BBB) and/or
abnormal blood supply and circulation of the central nervous
system. The BBB is an area consisting of specialized cells that
restrict passage of certain molecules from the bloodstream into
the brain.

CIRCULATORY SYSTEM DEVICES PANEL OF THE MEDICAL DEVICES
ADVISORY COMMITTEE

DATE: Jan. 25 and 26, 0800/1300

LOCATION: Holiday Inn, Two Montgomery Village Ave.,
Gaithersburg, Md.

CONTACT: James Swink, 301-796-6313

On Jan. 25, the committee will make recommendations
regarding regulatory classification of Automated External
Defibrillators to either reconfirm them as class III devices
requiring a premarket approval application or reclassify them
as class II devices requiring premarket notification known as a
510k.

On Jan. 26, the committee will make recommendations and
vote supplemental approval information for Abbott Laboratories
(ABT.N: ) Abbott Vascular unit’s RX Acculink Carotid Stent
System. The RX Acculink is indicated for treatment of patients
at risk for adverse events from carotid endarterectomy who
require carotid revascularization and meet the followting
criteria:

*Patients with neurological symptoms and more than 50
percent stenosis of the common or internal carotid artery or
patients without neurological symptoms and more than 80 percent
(high risk) or more than 70 percent (standard risk) stenosis of
the common or internal carotid artery

*Patients must have a reference vessel diameter within the
range of 4.0 and 9.0 mm at the target lesion.

NEUROLOGICAL DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY
COMMITTEE

DATE: Jan. 27-28, 0800/1300

LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.

CONTACT: James Engles, 301-796-7543

The committee will discuss and make recommendations
regarding the possible reclassification of devices indicated
for use in electroconvulsive therapy.

**CANCELLED**

ONCOLOGIC DRUGS ADVISORY COMMITTEE

DATE: Feb. 9, 0800/1300

LOCATION: FDA White Oak Campus, Building 31, 10903 New
Hampshire Ave., Silver Spring, Md.

CONTACT: Nicole Vesely, 301-796-9001

The committee will discuss a biologics license application
for Yervoy (ipilimumab), submitted by Bristol-Myers Squibb Co
(BMY.N: ). The proposed use for this product is for the treatment
of advanced melanoma in patients who have received prior
therapy.

Note: The FDA said in a notice Dec. 23: “This meeting has
been cancelled because the issues for which FDA was seeking the
scientific input of the committee have been resolved.”

ANESTHETIC AND LIFE SUPPORT DRUGS ADVISORY COMMITTEE

DATE: March 10, 0800/1300

LOCATION: FDA White Oak Campus, 10903 New Hampshire Ave.,
Building 31, Silver Spring, Md.

CONTACT: Kalyani Bhatt, 301-796-9001

The committee will receive updates about findings related
to degeneration in the nervous system in juvenile animals
exposed to anesthetic drugs, as well as results from human
epidemiological studies using anesthesia in children; discuss
the findings’ relevance to pediatric patients and provide
guidance for future studies; and discuss the potential
implications of these data upon the practice of pediatric
anesthesia as well as the communication of the risk of
sedative/anesthetic agents to prescribers and parents.

FOOD ADVISORY COMMITTEE

DATE: March 30 and 31, 0830/1230

LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.

CONTACT: Carolyn Jeletic, 301-436-1913

The committee will discuss whether available relevant data
demonstrate a link between children’s consumption of synthetic
color additives in food and adverse effects on behavior.
(Reporting by Lisa Richwine and Susan Heavey; Editing by Tim
Dobbyn)

U.S. FDA advisory meetings through March 31