Oscient: FDA advisory panel votes against Factive to treat sinusitis

By Elaine Rigoli

Tampa, Fla., Sept. 13 - Oscient Pharmaceuticals Corp. said the Food and Drug Administration's Anti-Infective Drugs Advisory Committee voted against two questions related to the company's pending supplemental New Drug Application that seeks approval for the use of Factive (gemifloxacin mesylate) tablets in treating acute bacterial sinusitis.

The Gaithersburg, Md., biopharmaceutical company said that, for the first question, the panel voted 10 to four that the data from the non-inferiority clinical trials of Factive in acute bacterial sinusitis were not sufficient to demonstrate efficacy in the treatment of acute bacterial sinusitis.

For the question "Do the safety and effectiveness data presented demonstrate an acceptable risk/benefit profile of Factive for the five-day treatment of patients with acute bacterial sinusitis," the panel voted 11 to two that the data did not support the approval of Factive for the treatment of acute bacterial sinusitis.

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