FDA Advisory Meetings（１月25日）
公開日時 2010/01/27 04:00
| Topic |
Advisory Committee |
Date |
| 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 |
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 |
| 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 |
| Selection of strains to be included in the influenza virus vaccine for the 2010-2011 influenza season |
Vaccines and Related Biological Products |
Feb. 22 |
| Salix' Xifaxan (rifaximin) for maintenance of remission of hepatic encephalopathy |
Gastrointestinal Drugs |
Feb. 23 |
| To be announced |
Risk Communication |
Feb. 25-26 |
| Bristol-Myers Squibb's belatacept injectable for use with kidney transplants to prevent rejection of the transplanted kidney |
Cardiovascular and Renal Drugs |
1-Mar |
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