Sept 5 Salix Pharmaceuticals Ltd said
the U.S. Food and Drug Administration would take more time to
review the drugmaker's new treatment for HIV-related diarrhea
and it now expects a regulatory decision by the end of the first
quarter of 2013.
The drug crofelemer aims to provide symptomatic relief of
non-infectious diarrhea in patients with HIV/AIDS on
"By taking no action at this time, the FDA has allowed for
the currently ongoing dialogue between Salix and the FDA to
continue," Salix's Chief Development Officer Bill Forbes said in
Salix and the FDA were primarily discussing the production
and control of the crofelemer active pharmaceutical ingredient -
"a complex mixture that is the first botanical product to be
reviewed by the agency for oral use."
About 1.2 million people in the United States are living
with HIV/AIDS and about 40 percent of those patients suffer from
either episodic or chronic diarrhea, Salix said.
Salix shares closed at $43.95 on Tuesday on the Nasdaq.