Monday June 22, 08:45 PM
U.S. FDA advisory meetings through Aug 13
THIS DIARY IS FILED AS THE FOOD AND DRUG ADMINISTRATION UPDATES ITS SCHEDULE. ALL TIMES EDT/GMT.
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 (Brussels: SOLB.BR - news) 's testosterone gel Androgel, Schering-Plough Corp's asthma drug Asmanex (mometasone furoate), Allergan Inc's eye pressure drops Combigan (brimonidine/timolol), Abbott Laboratories (NYSE: ABT - news) ' seizure drug Depakote (divalproex sodium), privately held Hill Dermaceuticals Inc's dermatitis product Derma-Smoothe F/S (fluocinolone acetate), Novartis AG (Virt-X: NOVN.VX - news) 's blood pressure medication Diovan (valsartan), Gilead Sciences Inc's hepatitis B drug Hepsera (adefovir dipivoxil), Pfizer Inc's hypertension drug Inspra (eplerenone), MiddleBrook Pharmaceuticals Inc's antibiotic Moxatag (amoxicillin), Sepracor Inc's 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 - news) 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 (NYSE: ACL - news) 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 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 (NYSE: DGX - news) . 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 (NYSE: KG - news) 's 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.
PERIPHERAL AND CENTRAL NERVOUS SYSTEM DRUGS ADVISORY COMMITTEE
DATE: Aug. 11, 0800/1200
LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.
The committee will discuss GE HealthCare's experimental radiopharmaceutical for use with a special type of brain imaging in patients with movement disorders. The product, called ioflupane I 123 injection with the proposed brand name DaTSCAN, aims to detect loss of functional nigrostriatal dopaminergic neurons by single photon emission computed tomography (SPECT) imaging in patients presenting with symptoms or signs of dopaminergic neurodegeneration. GE Healthcare is a unit of General Electric Co .
ADVISORY COMMITTEE FOR REPRODUCTIVE HEALTH DRUGS
DATE: Aug 13, 0800/1200
LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.
CONTACT: Kalyani Bhatt, 301-827-7001
The committee will discuss new biologics license applications from Amgen Inc for denosumab subcutaneous injection, 60 milligrams, for the proposed indications of the treatment and prevention of osteoporosis in postmenopausal women, and the treatment and prevention of bone loss in patients undergoing hormon 1696620898 term used to encompass therapies for hormone sensitive breast or prostate cancer administered to decrease sex hormone (estrogen or testosterone) levels. These therapies can result in increased bone loss. The drug's proposed trade name is Prolia.
(Reporting by Lisa Richwine and Susan Heavey; Editing by Tim Dobbyn) Keywords: FDA ADVISORY/DIARY
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