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Solithera FDA 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 Timeline 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

Further information

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