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
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