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FDA grants final approval for Uceris in the treatment of ulcerative colitis

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The FDA has granted final approval for budesonide rectal foam for the induction of remission in patients with mild to moderately active distal ulcerative colitis, according to a company press release.

The final FDA approval of Budesonide (Uceris, Salix Pharmaceuticals) 2 mg rectally-administered corticosteroid has been granted after expiration of the 45-day waiting period following the tentative approval granted on September 15, the release said.

This previous tentative approval followed two phase 3 studies that found significantly higher achievement of remission, and improvements in disease activity and rectal bleeding.

The product is expected to launch in early 2015.