Raptor’s Inhaled Levofloxacin Earns Qualified Infectious Disease Product Designation

Novato, Calif.-based Raptor Pharmaceuticals has gained qualified infectious disease product designation for MP-376, or inhaled levofloxacin, for three indications.

The designation was awarded for the treatment of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis and for those with noncystic fibrosis bronchiectasis, as well as in patients with nontuberculous mycobacteria.

As a result of receiving the designation, Raptor will gain 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.