For Cempra, feasibility of FDA-suggested study yet to be determined

Following Cempra ’s announcement Friday that the U.S. Food and Drug Administration did not approve its new drug applications for pneumonia drug solithromycin, the feasibility of an FDA-suggested study to progress approval forward has yet to be determined, according to acting CEO David Zaccardelli. Concerns over h epatotoxicity, or liver damage, surfaced at a briefing ahead of an FDA advisory committee hearing last month, and those same safety concerns, along with unspecified manufacturing deficiencies,…
Source: bizjournals.com Health Care:Pharmaceuticals headlines - Category: Pharmaceuticals Authors: Source Type: news