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Foradil®
(formoterol fumarateinhalation powder)
Foradil®
(formoterol fumarateinhalation powder)
FDA Advisory Committee Meeting
July 13, 2005
FDA Advisory Committee Meeting
July 13, 2005
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Regulatory HistoryRegulatory History
Eric A. Floyd, MS, MBA, PhDVice President – Global Head RDI
Drug Regulatory Affairs
Novartis
Eric A. Floyd, MS, MBA, PhDVice President – Global Head RDI
Drug Regulatory Affairs
Novartis
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Current SituationCurrent Situation
Safety concerns with LABAs have been expressed in public venues
The FDA would like to review the safety profile of LABAs
The safety data of Foradil® will be reviewed – Based on clinical trial data and post-approval
experience, formoterol continues to exhibit a favorable risk/benefit profile
Safety concerns with LABAs have been expressed in public venues
The FDA would like to review the safety profile of LABAs
The safety data of Foradil® will be reviewed – Based on clinical trial data and post-approval
experience, formoterol continues to exhibit a favorable risk/benefit profile
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LABA = Long-acting β2-agonist.
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TimelineTimeline
1990 1994 1997First approval
France Spain
1995
Italy Germany
2001
US
2005
13 millionperson-yr
ofexposure
Approved in 83 countries Approved in 83 countries
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Foradil® Aerolizer® in the USForadil® Aerolizer® in the US
The Foradil Aerolizer (formoterol fumarate inhalation powder) uses dry powder capsules for oral inhalation
12 µg bid was approved in the US for the following indications: – Maintenance treatment for asthma in individuals
≥ 5 yr of age – Acute prevention of exercise-induced bronchospasm
in individuals ≥ 5 yr of age, when administered on an occasional, as-needed basis
– COPD, including chronic bronchitis and emphysema
The Foradil Aerolizer (formoterol fumarate inhalation powder) uses dry powder capsules for oral inhalation
12 µg bid was approved in the US for the following indications: – Maintenance treatment for asthma in individuals
≥ 5 yr of age – Acute prevention of exercise-induced bronchospasm
in individuals ≥ 5 yr of age, when administered on an occasional, as-needed basis
– COPD, including chronic bronchitis and emphysema
MDI = Metered dose inhaler.
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Foradil® Outside the USForadil® Outside the US
Foradil 12 to 24 µg bid is a widely prescribed bronchodilator outside the US– For inhalation use in adults and children 5 yr of age
and older – Prophylaxis and treatment of bronchoconstriction in
patients with asthma– Prophylaxis of bronchospasm induced by inhaled
allergens, cold air, or exercise– Prophylaxis and treatment of bronchoconstriction in
patients with reversible or irreversible COPD, including chronic bronchitis and emphysema
In some countries, it is also approved as a MDI and a multidose dry powder inhaler 10 µg (Certihaler®)
Foradil 12 to 24 µg bid is a widely prescribed bronchodilator outside the US– For inhalation use in adults and children 5 yr of age
and older – Prophylaxis and treatment of bronchoconstriction in
patients with asthma– Prophylaxis of bronchospasm induced by inhaled
allergens, cold air, or exercise– Prophylaxis and treatment of bronchoconstriction in
patients with reversible or irreversible COPD, including chronic bronchitis and emphysema
In some countries, it is also approved as a MDI and a multidose dry powder inhaler 10 µg (Certihaler®)
MDI = Metered dose inhaler.
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Agenda for PresentationAgenda for Presentation
Introduction Eric A. Floyd, MS, MBA, PhDVice President – Global Head RDIDrug Regulatory AffairsNovartis
Safety of Foradil® Gregory P. Geba, MD, MPHVice President – US Head RDI
Clinical Development and Medical AffairsNovartis
Clinical Implications James F. Donohue, MDProfessor of MedicineChief of Pulmonary DivisionUniversity of North Carolina, Chapel Hill, NC
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Additional ExpertAdditional Expert
Gary Koch, PhD
Professor of Biostatistics
School of Public Health
University of North Carolina - Chapel Hill
Gary Koch, PhD
Professor of Biostatistics
School of Public Health
University of North Carolina - Chapel Hill
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Novartis produces and is the license holder for Foradil® Aerolizer® while Schering Corporation markets the compound in the US.
