Add to balance / Manage account | User: | Log out |
Prospect News home > News index > List of issuers O > Headlines for Oscient Pharmaceuticals Corp. > News item |
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.
© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere.
For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.