Salix Pharmaceuticals Submits Amendment for Rifaximin New Drug Application
RALEIGH, N.C.--(BUSINESS WIRE)--Nov. 25, 2003--Salix Pharmaceuticals, Ltd. (Nasdaq: SLXP - News) today announced that the Company has submitted an amendment to its New Drug Application (NDA) for Rifaximin to the U.S. Food and Drug Administration (FDA) in response to the FDA approvable letter of October 25, 2002. The Company is seeking approval to market Rifaximin, a non-systemic, gastrointestinal site-specific antibiotic, as a treatment for travelers' diarrhea. Under guidelines set forth in the Prescription Drug User Fee Act, upon acceptance of the amendment, the FDA has six months in which to review the amendment.
"We believe the information contained in the amendment provides a thorough and complete response to the items outlined in the FDA approvable letter," stated Dr. Art Kamm, Senior Vice President, Research and Development and Chief Development Officer, Salix. "The amendment includes results of a 399-patient Phase III study, results of two drug-drug interaction studies, results of a pharmacokinetics study and responses to Chemistry-Manufacturing Controls (CMC) queries. With the submission of this information, we look forward to the FDA completing its review of the Rifaximin application."
Rifaximin is a non-systemic, gastrointestinal site-specific antibiotic. Salix licensed Rifaximin from Alfa Wasserman S.p.A. More than 300 million tablets of Rifaximin have been sold/distributed in Italy since its approval in 1987. Currently, Rifaximin is approved in 13 countries worldwide. |
