The Food and Drug Administration has approved Salix Pharmaceuticals application to market its best-selling drug Xifaxan for serious liver disease, according to Bloomberg News.
The decision could mean an additional $1 billion in sales for Xifaxan, which generated $93 million in sales for Morrisville-based Salix during the first nine months of last year.
The antibiotic Xifaxan is currently approved for travelers' diarrhea. Salix officials anticipate that prescriptions for the liver disease hepatic encephalopathy ultimately could generate peak annual sales of $1 billion.
The disease, which affects 200,000 U.S. patients, impairs brain functions and can put patients in a coma.
Last month, an FDA advisory panel voted 14-4 to recommend approval of Xifaxan for treatment of serious liver disease. Trading in Salix shares was halted by Nasdaq for an entire day while the FDA panel deliberated and even after the panel made its recommendation.
The day after the vote was announced Salix shares jumped 20 percent and have continued to climb since.