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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).

In December 2016, Cempra, Inc. announced the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) relating to the company's new drug applications (NDAs) for oral and intravenous solithromycin for the treatment of community-acquired bacterial pneumonia (CABP) in adults. The CRL noted that additional clinical safety information and the satisfactory resolution of manufacturing facility inspection deficiencies would be required before the NDAs may be approved.

Development Status and FDA Approval Process for Solithera

DateArticle
Dec 29, 2016Cempra Receives Complete Response Letter From FDA For Solithromycin NDAs
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
Jan  4, 2015Cempra Announces Positive Topline Phase 3 Clinical Results for Oral Solithromycin in the Treatment of Community Acquired Bacterial Pneumonia
Sep  5, 2013Cempra's Solithromycin Demonstrates Safety and Tolerability in Patients With Chronic Liver Disease
May 20, 2013Cempra Presents Post-Phase II Analysis of Solithromycin's Efficacy and Safety
May 14, 2013Cempra, Inc. Signs Exclusive License and Development Agreement for Solithromycin

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