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Chart: Recent And Upcoming FDA Advisory Meetings

Executive Summary

Recent And Upcoming FDA Advisory Meetings



Recent And Upcoming FDA Advisory Meetings

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. 14

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