FDA Webview
X

Free FDA Notices

Panel to Discuss 2 NDAs for Skin Infections

10/15/2008

Federal Register Notice: FDA’s Anti-Infective Drugs Advisory Committee will meet 11/18, from 8 a.m. to 5 p.m., 11/19 from 8 a.m. to 5:30 p.m, and 11/20 from 8 a.m. to 12 noon at the Holiday Inn/College Park, The Ballroom, 10000 Baltimore Ave., College Park, MD. On 11/18, the committee will discuss the justification of the non-inferiority margin for complicated skin and skin structure infections. On 11/19 the committee will discuss a Theravance Corp. NDA for telavancin powder for reconstitution and intravenous administration proposed for the treatment of complicated skin and skin structure infection, and a Targanta Therapeutics Corp. NDA for oritavancin, proposed for treating complicated skin and skin structure infection. On 11/20, the committee will discuss an Aprida NDA for iclaprim proposed for treating complicated skin and skin structure infection. Contact Janie Kim, (301) 827- 7001. To view this notice, click here.

LATEST NEWS