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Date: Monday, December 22, 1997 FOR IMMEDIATE RELEASE Contact: FOOD AND ADMINISTRATION, Susan M. Cruzan: 3018276242, BROADCAST MEDIA: 3018273434, Consumer Inquires: 8005324440
Cystic fibrosis is an inherited condition that causes thick mucous secretions in the lungs, resulting in severely diminished lung function and chronic lung infections. Tobramycin, which was first approved in 1975 in injection form was reformulated for inhalation to reduce side effects associated with systemic therapy.
The new form of the antibiotic was designated as an orphan drug and will receive incentives under the Orphan Drug Act of 1983. It was approved in less than 6 months under an accelerated procedure of the Prescription Drug User Fee Act (PDUFA), the agency's user fee program.
"This is an important new therapy for cystic fibrosis patients," said Lead Deputy Commissioner Michael A. Friedman, M.D. "It also shows the benefits of FDA's Orphan Program and the effectiveness of our fast track procedures for medicines for serious diseases."
The new formulation of tobramycin was proven safe and effective in two placebocontrolled trials of about 500 patients with the chronic condition. The trials demonstrated improvement in lung function and reduction of the bacteria in sputum. The drug was administered, often in combination with other standard therapies, in a regimen of 28 days on drug and 28 days without drug therapy to reduce the potential for drug resistance.
Side effects reported in clinical trials included voice alteration and tinnitus (ringing in the ears).
Tobi will be marketed by PathoGenesis Corporation of Seattle, Washington.