U.S. FDA advisory meetings through Aug 4

THIS DIARY IS FILED AS THE FOOD AND DRUG ADMINISTRATION UPDATES ITS SCHEDULE. ALL TIMES EDT/GMT.

PSYCHOPHARMACOLOGIC DRUGS ADVISORY COMMITTEE

DATE: June 9-10, 0800/1200

LOCATION: Marriott Conference Centers, UMUC Inn and Conference Center, 3501 University Blvd. East, Adelphi, MD.

CONTACT: Diem-Kieu Ngo, 301-827-7001

On both days, the committee will discuss the following drugs and vote on whether they have been shown to be effective and acceptably safe for children and teenagers:

* AstraZeneca PLC's (AZN.L) (AZN.N) Seroquel, or quetiapine fumarate, for the acute treatment of schizophrenia in patients 13 to 17 years old, and the acute treatment of bipolar mania in those ages 10 to 17.

* Pfizer Inc's (PFE.N) Geodon, or ziprasidone hydrochloride, for the acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features in patients 10 to 17 years old.

* Eli Lilly and Co's (LLY.N) Zyprexa, or olanzapine, for the acute treatment of manic or mixed episodes associated with bipolar I disorder and the acute treatment of schizophrenia in adolescents.

GASTROENTEROLOGY AND UROLOGY DEVICES PANEL OF THE MEDICAL DEVICES

DATE: June 10, 0800/1200

LOCATION: Holiday Inn, 2 Montgomery Village Ave., Gaithersburg, Md.

CONTACT: Megan Mickal, 240-276-4151

The committee will discuss and make recommendations regarding general issues related to the use of ultrafiltration devices in the treatment of extracellular body fluid overload in heart failure patients. Specifically, the committee will discuss: Identifying the most appropriate heart failure patients for such treatments, determining where these treatments fit within the spectrum of treatment options, and defining what level of clinical evidence is necessary to adequately evaluate and provide labeling for these devices.

TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVISORY COMMITTEE

DATE: June 12, 0800/1200

LOCATION: Holiday Inn, 2 Montgomery Village Ave., Gaithersburg, Md.

CONTACT: William Freas or Rosanna Harvey, 301-827-0314

The committee will review and discuss a recent report from the UK Health Protection Agency attributing a case of variant Creutzfeldt-Jakob (vCJD) disease infection to treatment 11 years earlier with a vCJDimplicated plasma-derived coagulation factor VIII (pdFVIII) and whether this information or any other recent scientific information about the vCJD epidemic substantially alters FDA's risk assessment for U.S.-licensed preparations of pdFVIII products. The committee also will hear informational presentations on animal models of vCJD, diagnostic test development for transmissible spongiform encephalopathies (TSEs) and bovine spongiform encephalopathy (BSE) surveillance and risk management.

ARTHRITIS ADVISORY COMMITTEE

DATE: June 16, 0830/1230

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

CONTACT: Nicole Vesely, 301-827-6793

The committee will discuss a biologics license application from Savient Pharmaceuticals Inc (SVNT.O) for Krystexxa, known generically as pegloticase, as a therapy for patients with refractory gout.

PEDIATRIC ADVISORY COMMITTEE

DATE: June 23, 0830/1230

LOCATION: Hilton Hotel, 1750 Rockville Pike, Rockville, Md.

CONTACT: Carlos Pena, 301-827-3340

The committee will review and discuss reports by the agency, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, for privately held Nycomed's asthma drug Alvesco (ciclesonide), Solvay SA's (SOLB.BR) testosterone gel Androgel, Schering-Plough Corp's asthma drug SGP.N Asmanex (mometasone furoate), Allergan Inc's (AGN.N) eye pressure drops Combigan (brimonidine/timolol), Abbott Laboratories' (ABT.N) seizure drug Depakote (divalproex sodium), privately held HillDermaceuticals Inc's dermatitis product Derma-Smoothe F/S (fluocinolone acetate), Novartis AG's (NOVN.VX) blood pressure medication Diovan (valsartan), Gilead Sciences Inc's (GILD.O) hepatitis B drug Hepsera (adefovir dipivoxil), Pfizer Inc's hypertension drug (PFE.N) Inspra (eplerenone), MiddleBrook Pharmaceuticals Inc's MBRK.O antibiotic Moxatag (amoxicillin), Sepracor Inc's SEPR.O nasal allergy medication Omnaris (ciclesonide), and Novartis' bone drug Zometa (zoledronic acid).

DERMATOLOGIC AND OPHTHALMIC DRUGS ADVISORY COMMITTEE

DATE: June 26, 0800/1200

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

CONTACT: Paul Tran, 301-827-7001

The committee will discuss a new drug application from Ista Pharmaceuticals (ISTA.O) for Bepreve (bepotastine besilate) ophthalmic solution, 1.5%, for the treatment of ocular itching associated with allergic conjunctivitis, and a new drug application from River Plate Biotechnology Inc for sodium hyaluronate ophthalmic solution for the treatment of the signs and symptoms of dry eye disease. Alcon Inc ACL.N holds U.S. marketing rights to River Plate's product.

DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE WITH THE ANESTHETIC AND LIFE SUPPORT DRUGS ADVISORY COMMITTEE AND THE NONPRESCRIPTION DRUGS ADVISORY COMMITTEE

DATE: June 29-30, 0800/1200

LOCATION: Marriott Conference Centers, UMUC Inn and Conference Center, 3501 University Blvd. East, Adelphi, Md.

CONTACT: Elaine Ferguson, 301-827-7001

The committees will discuss how to address the public health problem of liver injury related to the use of acetaminophen in both over-the-counter and prescription products.

ONCOLOGIC DRUGS ADVISORY COMMITTEE

DATE: July 15, 0800/1200

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

CONTACT: Nicole Vesely, 301-827-6793

The committee will discuss a new drug application from Johnson & Johnson (JNJ.N) for trabectedin intravenous infusion in combination with Doxil for the treatment of patients with relapsed ovarian cancer. The proposed trade name for trabectedin is Yondelis.

The committee also will discuss a supplemental new drug application from Johnson & Johnson for intravenous infusion of Doxil in combination with docetaxel for the treatment of patients with locally advanced or metastatic breast cancer who have received prior anthracycline treatment.

HEMATOLOGY AND PATHOLOGY DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE

DATE: July 17, 0800/1200

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

CONTACT: Louise Magruder, 240-276-1248

The committee will discuss and make recommendations on a Clinical Laboratory Improvement Amendment Waiver application for the HemoCue WBC Analyzer, sponsored by HemoCue Inc, a unit of Quest Diagnostics (DGX.N). The HemoCue WBC system is indicated for use for quantitative determination of white blood cell (WBC) counts in capillary or venous whole blood and can be used in clinical laboratories and at point-of-care settings.

CARDIOVASCULAR AND RENAL DRUGS ADVISORY COMMITTEE

DATE: July 28, 0800/1200

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

CONTACT: Elaine Ferguson, 301-827-7001

The committee will discuss King Pharmaceuticals Inc's KG.N binodenoson injection, a short-acting coronary vasodilator, for use as an adjunct to noninvasive myocardial perfusion imaging tests to detect perfusion abnormalities in patients with known or suspected coronary artery disease. The drug's brand name is Corvue.

CARDIOVASCULAR AND RENAL DRUGS ADVISORY COMMITTEE

DATE: July 29, 0800/1200

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

CONTACT: Elaine Ferguson, 301-827-7001

The committee will discuss supplemental new drug application from Boehringer Ingelheim for telmisartan tablets for the proposed indication of reduction in the risk of myocardial infarction, stroke, death from cardiovascular causes, or hospitalization for congestive heart failure in patients 55 years or older who are at high risk of developing major cardiovascular events.

PSYCHOPHARMACOLOGIC DRUGS ADVISORY COMMITTEE

DATE: July 30, 0800/1200

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

CONTACT: Cicely Reese, 301-827-7001

The committee will discuss the safety and efficacy of new drug application from Schering-Plough for Saphris for acute treatment of schizophrenia in adults and acute treatment of manic or mixed episodes of bipolar I disorder in adults. The drug's generic name is asenapine.

ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE AND CLINICAL PHARMACOLOGY

DATE: Aug 4, 0800/1200

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

CONTACT: Janie Kim, 301-827-7001

The committee will discuss bioequivalence recommendations for oral vancomycin hydrochloride capsule drug products. (Reporting by Lisa Richwine and Susan Heavey; Editing by Tim Dobbyn)