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FDA Grants QIDP Designation To Aradigm Corporation (ARDM)’s Inhaled Antibiotic


5/20/2014 8:56:27 AM

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HAYWARD, Calif.--(BUSINESS WIRE)--Aradigm Corporation (OTC BB: ARDM.OB) (the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has designated the Company’s lead inhaled antibiotic candidate, Pulmaquin®, as a Qualified Infectious Disease Product (QIDP). The QIDP designation, granted for treatment of non-cystic fibrosis bronchiectasis (non-CF BE) patients with chronic lung infections with Pseudomonas aeruginosa, will make Pulmaquin eligible to benefit from certain incentives for the development of new antibiotics provided under the Generating Antibiotic Incentives Now Act (GAIN Act). These incentives include priority review and eligibility for fast-track status. Further, if ultimately approved by the FDA, Pulmaquin is eligible for an additional five-year extension of Hatch-Waxman exclusivity.

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