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Recent And Upcoming FDA Advisory Committee Meetings

Topic

Advisory Committee

Date

Novartis' Ilaris (canakinumab) for treatment of gouty arthritis attacks

Arthritis

June 21

Shire's Firazyr (icatibant) for treatment of acute attacks of hereditary angioedema

Pulmonary and Allergy Drugs

June 23

Development issues for cellular and gene therapy products for retinal disorders, including efficacy endpoints in children and adults, potential safety issues related to repeat or second eye administration, and evaluation of product delivery into target site

Cellular, Tissue and Gene Therapies

June 29

Seattle Genetics' Adcetris (brentuximab vedotin) for relapsed or refractory Hodgkin's lymphoma and relapsed or refractory systemic anaplastic large cell lymphoma

Oncologic Drugs

July 14

Bristol-Myers Squibb/AstraZeneca's dapagliflozin for glycemic control in adults with type 2 diabetes

Endocrinologic and Metabolic Drugs

July 19

Development program of an investigational gastroenterology drug; after a brief open period, the meeting will be closed to allow discussion including proprietary information

Gastrointestinal Drugs and Drug Safety and Risk Management

July 20

CLOSED

Centocor Ortho Biotech's Remicade (infliximab) for pediatric patients with moderately to severely active ulcerative colitis

Gastrointestinal Drugs

July 21

Topics including implementation of Quality by Design principles

Pharmaceutical Science and Clinical Pharmacology

July 27

Topics

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