FDA Grants Orphan Drug Status to Mpex's Pulmonary Infection Drug
Posted on: Wednesday, 5 March 2008, 06:00 CST
Mpex Pharmaceuticals has reported that the FDA's Office of Orphan Products Development has granted orphan drug designation for levofloxacin solution for inhalation for the treatment of pulmonary infections due to Pseudomonas aeruginosa and other bacteria in patients with cystic fibrosis.
The orphan drug designation will entitle Mpex to a seven-year period of exclusive marketing rights for MP-376 for the orphan indication following the date of the drug's marketing approval by the FDA. Orphan status also enables Mpex to apply for research funding, tax credits for certain research expenses, and a waiver from FDA user fees. Levofloxacin is the active pharmaceutical ingredient in MP-376, the company's proprietary levofloxacin solution for inhalation.
Daniel Burgess, president and CEO of Mpex, said: "This helps reinforce our belief that MP-376 has the potential to provide a valuable new treatment option in the management of cystic fibrosis. We look forward to working with CF patients, treatment providers and the FDA to rapidly advance this product candidate through to commercialization."
Source: Datamonitor
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