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Solithera Approval Status

  • FDA approved: No
  • Brand name: Solithera
  • Generic name: solithromycin
  • Company: Cempra, Inc.
  • Treatment for: Pneumonia

Solithera (solithromycin) is a next-generation oral and intravenous fluoroketolide in clinical development for the treatment of moderate to moderately-severe community acquired bacterial pneumonia (CABP).

Development Status and FDA Approval Process for Solithera

Nov  4, 2016FDA Advisory Committee Votes That Efficacy Results of Cempra's Solithromycin Outweigh Risks for Community-Acquired Bacterial Pneumonia
Jul  5, 2016Cempra Announces FDA Acceptance of Solithera New Drug Applications in the Treatment of Community-Acquired Bacterial Pneumonia
May  1, 2016Cempra Completes NDA Submissions for Solithromycin in the Treatment of Community-Acquired Bacterial Pneumonia
Aug 19, 2015FDA Grants Fast Track Designation to Cempra for Solithromycin in the Treatment of Community Acquired Bacterial Pneumonia

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