Oscient: FDA to review Factive sinusitis treatment

By Elaine Rigoli

Tampa, Fla., June 28 - The Food and Drug Administration has informed Oscient Pharmaceuticals Corp. that the FDA's anti-infective drugs advisory committee will review the supplemental New Drug Application for Factive (gemifloxacin mesylate) tablets for the treatment of acute bacterial sinusitis on Sept. 12.

The acute bacterial sinusitis sNDA seeks approval for the treatment of this infection with Factive in a five-day treatment regimen.

Oscient said the sNDA contains data from five phase 3 trials involving more than 1,800 patients receiving Factive and 500 patients receiving a comparator.

The sNDA for the acute bacterial sinusitis indication was submitted in November 2005.

The FDA notified the company of its refusal to file the application in January of this year. After discussions with the FDA, and at the company's request, the FDA filed the sNDA over protest.

The FDA has set an action date for making a decision on the acute bacterial sinusitis sNDA of Dec. 15, 2006.

Oscient is a biopharmaceutical company located in Waltham, Mass.

© 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.