TITLE

Salix Anticipates Receipt of FDA Complete Response Letter on XIFAXAN(R) 550 Mg Tablets Supplemental New Drug Application

PUB. DATE
March 2011
SOURCE
Biomedical Market Newsletter;3/21/2011, p481
SOURCE TYPE
Periodical
DOC. TYPE
Article
ABSTRACT
The article reports on Salix Pharmaceuticals Ltd.'s anticipation of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the XIFAXAN(R) (rifaximin) 550 milligrams supplemental New Drug Application (sNDA). It says that Salix expects receiving CRL for the proposed indication of irritable bowel syndrome (IBS)-related bloating and non-constipation IBS' treatment. Meanwhile, CRL is being issued when an application's review cycle is already complete.
ACCESSION #
60100974

 

Share

Read the Article

Courtesy of THE LIBRARY OF VIRGINIA

Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics