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FDA　Advisory　Meetings（１月18日）

公開日時　2010/01/20 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, 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 (CANCELED) 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
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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