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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

DateArticle
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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