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Qualified Infectious Disease Product (QIDP) Designation for MP-376 (Inhaled Levofloxacin) for Three Indications

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Additional Relevant Details Raptor Pharmaceuticals announced the FDA has granted Qualified Infectious Disease Product (QIDP) designation to MP-376, the company's proprietary inhaled levofloxacin, for three distinct indications: for the treatment of chronic pulmonary infections due toPseudomonas aeruginosa, in patients with cystic fibrosis (CF) and in patients with non-cystic fibrosis bronchiectasis (BE), and in patients with nontuberculous mycobacteria (NTM).  The designations "provides Raptor with significant incentives for the development of MP-376, including priority review by the FDA, eligibility for Fast Track designation and a five-year extension of marketing exclusivity under the Hatch-Waxman Act."
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Catalyst Date
Occurred on:
Mar 16, 2016
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Related Keywords Qualified Infectious Disease Product, Mp-376, Inhaled Levoflexin, Chronic Pulmonary Infections, Pseudomonas Aeruginosa, Cystic Fibrosis, Non-cystic Fibrosis Bronchiectasis, Nontuberculous Mycobacteria