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Cempra Announces FDA Acceptance of Solithera New Drug Applications in the Treatment of Community-Acquired Bacterial Pneumonia

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Additional Information

Additional Relevant Details Cempra's New Drug Applications (NDAs) for the approval of SolitheraTM (solithromycin) as a treatment for community-acquired bacterial pneumonia (CABP) have been accepted for filing by the U.S. Food and Drug Administration (FDA). The acceptance of the two NDAs, one for the intravenous formulation and one for oral capsules, indicates the applications are sufficiently complete to permit a substantive review by the FDA.
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Occurred on:
Jul 05, 2016
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Related Keywords Nda, Solithera