Cempra's solithromycin receives QIDP designation from FDA Cempra announced that the U.S. Food and Drug Administration has designated oral solithromycin as a Qualified Infectious Disease Product for the indication of community-acquired bacterial pneumonia. The QIDP designation is expected to enable Cempra to benefit from certain incentives for the development of new antibiotics, including priority review, and a five year extension of new chemical entity exclusivity. An oral formulation of solithromycin is currently being evaluated in a phase 3 trial for the treatment of community-acquired bacterial pneumonia. Cempra is planning to initiate an intravenous-to-oral phase 3 step-down phase 3 trial during 2H13.
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