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
|Dec 29, 2016||Cempra Receives Complete Response Letter From FDA For Solithromycin NDAs|
|Nov 4, 2016||FDA Advisory Committee Votes That Efficacy Results of Cempra's Solithromycin Outweigh Risks for Community-Acquired Bacterial Pneumonia|
|Jul 5, 2016||Cempra Announces FDA Acceptance of Solithera New Drug Applications in the Treatment of Community-Acquired Bacterial Pneumonia|
|May 1, 2016||Cempra Completes NDA Submissions for Solithromycin in the Treatment of Community-Acquired Bacterial Pneumonia|
|Aug 19, 2015||FDA Grants Fast Track Designation to Cempra for Solithromycin in the Treatment of Community Acquired Bacterial Pneumonia|
|Jan 4, 2015||Cempra Announces Positive Topline Phase 3 Clinical Results for Oral Solithromycin in the Treatment of Community Acquired Bacterial Pneumonia|
|Sep 5, 2013||Cempra's Solithromycin Demonstrates Safety and Tolerability in Patients With Chronic Liver Disease|
|May 20, 2013||Cempra Presents Post-Phase II Analysis of Solithromycin's Efficacy and Safety|
|May 14, 2013||Cempra, Inc. Signs Exclusive License and Development Agreement for Solithromycin |
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