Home » Drug Information » FDA Approved Drugs » 1997
Medical Areas: Pulmonary/Respiratory Diseases | Family Medicine
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Tilade (nedocromil sodium)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Rhone Poulenc Rorer
Approval Status: Approved November 1997
Treatment Area: asthma
Tilade Nebulizer Solution (nedocromil sodium inhalation
solution) has been approved as a treatment for mild to moderate
asthma in patients two years of age and older. Tilade Solution is a
new dosage form of Rhone-Poulenc Rorer's Tilade Inhaler, an
inhaled nonsteroidal anti-inflammatory agent for the preventive
management of mild to moderate asthma. A nebulizer is a device used
to reduce liquid medication to fine particles so that it can be
delivered by inhalation to the respiratory tract.
The safety and efficacy of Tilade Nebulizer Solution was studied
in eight randomized, double-blind, parallel, placebo-controlled
U.S. clinical trials of 1,403 patients with mild to moderate
asthma. Patients treated with Tilade Nebulizer Solution experienced
statistically significant reductions in asthma symptoms, and a
greater increase in morning peak expiratory flow rates vs.
The most common adverse events from all eight clinical trials
reported frequently for those receiving Tilade Nebulizer Solution
vs. placebo were sore throat, sinusitis, and fever.