WEDNESDAY, Jan. 17, 2007 (HealthDay News) -- Lialda, a drug designed to induce remission in people with active ulcerative colitis, has been approved by the U.S. Food and Drug Administration, British maker Shire announced.
It marked the first time the agency has approved the drug's active ingredient, mesalamine, in once-daily oral dose, the company said in a statement.
Ulcerative colitis, an inflammatory bowel disease, produces sores (ulcers) inside the large intestine. Symptoms can include cramps, bloating, diarrhea, bleeding, fatigue and weight loss.
The chronic autoimmune disease affects 500,000 Americans, Shire said.
Lialda's safety and effectiveness were established in two Phase III clinical studies involving people with active, mild-to-moderate ulcerative colitis, compared to a non-medicinal placebo. Commonly reported side effects included headache and flatulence, the company said.
More information
To learn more about ulcerative colitis, visit the U.S. National Digestive Diseases Information Clearinghouse.
