FDA Advisory Meetings（７月6日）
公開日時 2009/07/06 04:00
| Topic |
Advisory Committee |
Date |
| Discussion of pediatric and adolescent indications for AstraZeneca's Seroquel (quetiapine), Pfizer's Geodon (ziprasidone) and Lilly's Zyprexa (olanzapine) to treat schizophrenia and bipolar disorder |
Psychopharmacologic Drugs |
June 9-10 |
| Savient's Krystexxa (pegloticase) for treatment failure gout |
Arthritis Drugs |
16-Jun |
| Discussion of FDA reports on 12 drugs as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act |
Pediatric Advisory Committee |
23-Jun |
| ISTA Pharmaceuticals' Bepreve (bepotastine) ophthalmic solution, 1.5%, for ocular itching associated with allergic conjunctivitis and River Plate Biotech's sodium hyaluronate ophthalmic solution, 0.18%, for signs and symptoms of dry eye disease |
Dermatologic and Ophthalmic Drugs |
26-Jun |
| Discussion of risk management and other possible solutions for reducing liver problems linked to the misuse of acetaminophen in OTC and prescription products |
Nonprescription Drug, Drug Safety and Risk Management and Anesthetic and Life Support Drugs |
June 29-30 |
| Centocor Ortho Biotech Products' Yondelis (trabectedin) for use in combination with Doxil (doxorubicin injection) to treat relapsed ovarian cancer, and the sNDA for Doxil in combination with docetaxel for locally advanced or metastatic breast cancer |
Oncologic Drugs |
15-Jul |
| King Pharmaceuticals' binodenoson for use as a short-acting coronary vasodilator in adjunct with noninvasive myocardial imaging tests to detect perfusion abnormalities in patients with known or suspected coronary artery disease |
Cardiovascular and Renal Drugs |
28-Jul |
| Boehringer Ingelheim's telmisartan tablets for reduction in the risk of myocardial infarction, stroke, death from cardiovascular causes or hospitalization for congestive heart failure in high-risk patients 55 years or older |
Cardiovascular and Renal Drugs |
29-Jul |
| Schering-Plough's Saphris (asenapine) for acute treatment of schizophrenia and acute treatment of manic or mixed episodes of bipolar I disorder, both in adults |
Psychopharmacologic Drugs |
30-Jul |
| GE Healthcare's radiopharmaceutical DaTSCAN (ioflupane I 123 injection) for a special type of brain imaging in patients with movement disorders |
Peripheral and Central Nervous System Drugs |
Aug. 11 |
| Amgen's Prolia (denosumab) for treatment and prevention of osteoporosis in postmenopausal women, and for treatment and prevention of bone loss in patients undergoing hormone ablation for prostate or breast cancer |
Reproductive Health Drugs |
Aug. 13 |
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