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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

General Information

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.

Clinical Results

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. placebo.

Side Effects

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.