Geninax AC review
Executive Summary
FDA's Anti-Infective Drugs Advisory Committee will meet on Sept. 11 to discuss Schering-Plough's NDA for I.V. and oral garenoxacin (proposed trade name Geninax) for acute bacterial exacerbation of chronic bronchitis, acute bacterial sinusitis, community-acquired pneumonia, complicated and uncomplicated skin and skin structure infections, and complicated intra-abdominal infections. The committee will discuss Oscient Pharmaceuticals' sNDA for Factive (gemifloxacin) for acute bacterial sinusitis on Sept. 12 (1"The Pink Sheet" July 3, 2006, In Brief). The two-day meeting will be held from 8 am to 5 pm each day at the Hilton-Gaithersburg in Maryland. [Editor's note: To 2watch a webcastor order a video/DVD of advisory committee meetings, visit FDAAdvisoryCommittee.com]...
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