Salix Pharmaceuticals Ltd (SLXP) said Monday the FDA granted tentative approval for Uceris (budesonide) rectal foam for the induction of remission in patients with active mild-to-moderate distal ulcerative colitis (UC) extending up to 40cm from the anal verge.
The Uceris rectal foam is a rectally administered corticosteroid that overcomes treatment limitations associated with currently approved therapies which are often ineffective due to insufficient distribution of active drug to the distal colon.
The FDA's tentative approval of this product means that Salix's product meets all of the FDA's manufacturing quality and clinical safety and efficacy standards and will be granted final approval upon the resolution of patent issues. Salix anticipates resolution of patent issues early in the fourth quarter of 2014 and the launch of Uceris rectal foam during the first quarter of 2015.
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.