FDA Advisory Meetings（９月７日）
公開日時 2009/09/09 04:00
| Topic |
Advisory Committee |
Date |
| Genzyme's Clolar (clofarabine) injection for added indication of acute myeloid leukemia in patients over age 60 with at least one unfavorable prognostic factor; Vion's Onrigin (laromustine) injection for remission induction in patients over 60 with de novo poor-risk AML |
Oncologic Drugs |
Sept. 1 |
| Gloucester's Istodax (romidepsin) for cutaneous T-cell lymphoma, including relief of pruritus; Allos Therapeutics' Folotyn (pralatrexate) for relapsed or refractory peripheral T-cell lymphoma |
Oncologic Drugs |
Sept. 2 |
| GlaxoSmithKline's Human Papillomavirus vaccine for use in females, and Merck's HPV vaccine Gardasil for use in males |
Vaccines and Related Biological Products |
Sept. 9 |
| Auxilium Pharmaceuticals' BLA for clostridial collagenase for advanced Dupuytren's disease |
Arthritis Drugs |
Sept. 16 |
| Neuromed's Exalgo (modified-release hydromorphone) for moderate to severe pain in opioid-tolerant patients |
Anesthetic Life Support Drugs and Drug Safety and Risk Management |
Sept. 23 |
| Discussion of new data for Purdue's Oxycontin (oxycodone controlled-release) tablets for moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time |
Anesthetic Life Support Drugs and Drug Safety and Risk Management |
Sept. 24 |
| Schering Plough's PegIntron (peginterferon alfa-2b) as an adjuvant to surgery for metastatic melanoma, and GlaxoSmithKline's Amala (pazopanib) for advanced renal cell carcinoma |
Oncologic Drugs |
Oct. 5 |
| ApoPharma's Ferriprox (deferiprone) as an iron chelating agent to treat iron overload or build-up in patients with transfusion-dependent thalassemia or other transfusion-dependent anemias |
Oncologic Drugs |
Oct. 6 |
| Pfizer's Selzentry (maraviroc) for supplemental indication to treat antiretroviral-naïve patients with chemokine (c-c motif) receptor 5 (CCR5) tropic human immunodeficiency virus |
Antiviral Drugs |
Oct. 8 |
| Acorda Therapeutics' Amaya (fampidine-SR) to improve walking ability in multiple sclerosis patients |
Peripheral and Central Nervous System Drugs |
Oct. |
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