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.
ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE
DATE: June 2, 0800/1200
LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.
CONTACT: Janie Kim, 301-827-7001
The committee will discuss new drug application from Advanced Life Sciences (ADLS.OB) for cethromycin oral tablets for the proposed indication of outpatient treatment of adults with mild to moderate community-acquired pneumonia.
ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE
DATE: June 3, 0800/1200
LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.
CONTACT: Janie Kim, 301-827-7001
The committee will discuss issues related to the development of drugs for the treatment of tuberculosis, including drug resistant tuberculosis. Areas of discussion include diagnosis, treatment duration, study design (such as endpoints and duration of follow-up) and safety issues.
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.
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)
