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Article: PathoGenesis Corp. Announces NDA Filing
- Article from:
- PR Newswire
- Article date:
- July 10, 1997
CopyrightCOPYRIGHT 1997 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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SEATTLE, July 10 /PRNewswire/ -- PathoGenesis Corp. (Nasdaq: PGNS) announced today that it has completed the filing of a New Drug Application (NDA) for its lead product TOBI(TM) (tobramycin for inhalation) to treat chronic lung infections in people with cystic fibrosis. PathoGenesis has been submitting sections of the NDA to the Food and Drug Administration (FDA) on a rolling submission basis since April. The FDA has granted TOBI an expedited review.
TOBI is a stable, premixed, proprietary formulation of the antibiotic tobramycin for delivery by inhalation using a nebulizer. Two double-blind, placebo-controlled Phase III clinical trials of TOBI were ...