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FDA's Advisory Meetings（6月11日）

公開日時　2012/06/14 04:00

Topic
 Advisory Committee Date
Gilead Sciences’ “Quad” combination tablet containing elvitegravir, cobicistat, emtricitabine and tenofovir, for treatment of HIV-1 in antiretroviral-naïve adults Antiviral Drugs 11-May
Janssen's Xarelto (rivaroxaban) to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndrome in combination with aspirin alone or with aspirin plus clopidogrel or ticlopidine Cardiovascular and Renal Drugs 23-May
Pfizer's Vyndaqel (tafamidis meglumine) to treat transthyretin familial amyloid polyneuropathy Peripheral and Central Nervous System Drugs 24-May
Sanofi-Aventis' semuloparin for prophylaxis of venous thromboembolism in patients receiving chemotherapy for locally advanced or metastatic pancreatic or lung cancer or for locally advanced or metastatic solid tumors with a VTE risk of 3 or greater Oncologic Drugs 20-Jun
Onyx Pharmaceuticals' Kyprolis (carfilzomib) for relapsed and refractory multiple myeloma in patients who have received at least two prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent Oncologic Drugs 20-Jun
Recent research on communicating and understanding uncertainty, and risk perception and information seeking when facing multiple risks Risk Communication 29-Jun
GSK's Tykerb (lapatinib) in combination with trastuzumab for metastatic breast cancer patients whose tumors overexpress HER2 and who have received prior trastuzumab therapy(s); evaluation of radiographic review in randomized clinical trials using progression-free survival as a primary endpoint in non-hematologic malignancies Oncologic Drugs 24-Jul
Whether pre-surgical identification of clear cell carcinoma of the kidney using an imaging test provides useful clinical information Oncologic Drugs 25-Jul
Benefits and risks to public health, including the potential for abuse, of drugs containing hydrocodone, either combined with other analgesics or as an antitussive; meeting at the request of the Drug Enforcement Administration Drug Safety and Risk Management Oct. 29-30
 
 
 
 
 

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