The US FDA has approved Warner Chilcott's 400mg mesalamine product as new ulcerative colitis therapy, to be marketed as Delzicol.
Warner expects to commercially launch Delzicol in March 2013.
Delzicol delayed-release capsules are indicated to treat patients with mild to moderate active ulcerative colitis and to maintain remission of the disease.
The recommended Delzicol dose to treat mild to moderate active ulcerative colitis in adults is two 400mg capsules three times daily (total daily dose of 2.4g), for a duration of six weeks.
Recommended Delzicol dose to maintain remission of the disease is 1.6g daily, in divided doses.
Source:
http://regulatoryaffairs.pharmaceutical-business-review.com/news/fda-approves-warner-delzicol-ulcerative-colitis-therapy-070213
