Salix:s FDA Grants Tentative Approval For Uceris Rectal Foam

(RTTNews) - 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.