FDA Advisory Meetings（１月４日）
公開日時 2010/01/08 04:00
| Topic |
Advisory Committee |
Date |
| Discussion of endpoints and other clinical trial design issues in the development of antibacterial products for community-acquired bacterial pneumonia |
Anti-Infective Drugs |
Dec. 9 |
| Gilead Science's inhaled aztreonam to treat respiratory symptoms and pulmonary function in cystic fibrosis patients with bacterial infection Pseudomonas aeruginosa |
Anti-Infective Drugs |
Dec. 10 |
| Discussion of FDA expectations for development of pediatric formulation of cancer drugs and dosing regimens in infants and toddlers with cancer |
Pediatric Oncology Subcommittee |
Dec. 15 |
| AstraZeneca's sNDA for Crestor (rosuvastatin) to prevent cardiovascular disease based on results of the JUPITER trial |
Endocrinologic and Metabolic Drugs |
Dec. 15 |
| Updates on research programs in several CBER laboratories, the Division of Viral Products, and the Office of Vaccines Research and Review |
Vaccines & Related Biological Products |
Dec. 15 |
| OSI Pharmaceuticals' Tarceva (erlotinib) for non-small cell lung cancer, and GlaxoSmithKline's Tykerb (lapatinib) for use in combination with an aromatase inhibitor to treat hormone-sensitive advanced or metastatic breast cancer |
Oncologic Drugs |
Dec. 16 |
| Photocure ASA's Hexvix (hexaminolevulinate as hydrochloride) kit for the preparation of the diagnostic imaging agent Hexvix for intravesical use |
Oncologic Drugs |
Dec. 17 |
| Forest Laboratories' sNDA for nebivolol for chronic heart failure |
Cardiovascular and Renal Drugs |
Jan. 11 |
| On Jan. 12, Actelion Pharmaceuticals' Zavesca (miglustat) to treat progressive neurological manifestations in patients with Niemann-Pick Disease; on Jan. 13, Orphan Europe SARL's Carbaglu (carglumic acid) for hyperammonemia in patients with N acetyl glutamate synthetase deficiency |
Endocrinolgic and Metabolic Drugs |
Jan. 12-13 |
| Lilly's Cymbalta (duloxetine) for chronic pain |
Anesthetic and Life Support Drugs |
Jan. 28 |
| Cell Therapeutics' Pixuvri (pixantronedimaleate injection) for single agent treatment of recurring or refractory aggressive non-Hodgkins lymphoma in patients who have received two or more prior lines of therapy; ChemGenex' Omapro (omacetaxine mepesuccinate injection) for treatment of adults with chronic myeloid leukemia who have the Bcr-Abl T315I mutation and have failed on imatinib therapy |
Oncologic Drugs |
Feb. 10 |
| Salix' Xifaxan (rifaximin) for maintenance of remission of hepatic encephalopathy |
Gastrointestinal Drugs |
Feb. 23 |
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