Rolling submission of Solitaire (solithromycin) to FDA for community-acquired bacterial pneumonia now complete- Cempra

Cempra has announced the completion of its rolling submission of the New Drug Applications (NDA) for Solitaire (solithromycin) to the FDA for the treatment of community-acquired bacterial pneumonia (CABP). Based on the Qualified Infectious Disease Product (QIDP) designation by the FDA of solithromycin, Cempra has Priority Review and has been granted Fast Track for both the oral capsule and intravenous formulations for the treatment of CABP.

This could result in an FDA decision on solithromycin’s NDA within eight months, or by the end of 2016, based on the Prescription Drug User Fee Act (PDUFA) performance goals. Cempra’s submissions in the EU remain on track for completion by the end of June 2016.