Content about Management of ulcerative colitis

February 4, 2014

Salix Pharmaceuticals announced that the Food and Drug Administration has accepted for filing a new drug application for Budesonide 2 mg Rectal Foam for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.

RALEIGH, N.C. — Salix Pharmaceuticals last week announced that the Food and Drug Administration has accepted for filing a new drug application for Budesonide 2 mg Rectal Foam for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.

The FDA has issued an action date of Sept. 15, 2014 under the Prescription Drug User Fee Act. 

January 8, 2014

Takeda Pharmaceutical has started a late-stage clinical trial program of its experimental drug for inflammatory bowel disease in Japan, the company said Wednesday.

OSAKA, Japan — Takeda Pharmaceutical has started a late-stage clinical trial program of its experimental drug for inflammatory bowel disease in Japan, the company said Wednesday.

Takeda announced the start of two phase-3 trials of MLN0002 (vedolizumab) in patients with severe ulcerative colitis and Crohn's disease. The trials are designed to find out the efficacy, safety and effects on the body of the drug, particularly to see if patients show a response after 10 weeks of treatment and disease remission after 60 weeks.

December 10, 2013

An expert panel at the Food and Drug Administration has given a thumbs-up to an experimental drug made by Takeda Pharmaceutical Co. for treating ulcerative colitis and Crohn's disease, the drug maker said.

DEERFIELD, Ill. — An expert panel at the Food and Drug Administration has given a thumbs-up to an experimental drug made by Takeda Pharmaceutical Co. for treating ulcerative colitis and Crohn's disease, the drug maker said.

May 15, 2013

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating ulcerative colitis, the agency said Wednesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating ulcerative colitis, the agency said Wednesday.

February 8, 2013

The Food and Drug Administration has approved a new drug from Warner Chilcott for treating ulcerative colitis, the drug maker said.

DUBLIN — The Food and Drug Administration has approved a new drug from Warner Chilcott for treating ulcerative colitis, the drug maker said.

Warner Chilcott announced the approval of mesalamine in the 400-mg strength.

The company plans to market the drug under the brand name Delzicol and launch it in March.

January 16, 2013

The Food and Drug Administration has approved an ulcerative colitis drug made by Santarus, the drug maker said.

SAN DIEGO — The Food and Drug Administration has approved an ulcerative colitis drug made by Santarus, the drug maker said.

Santarus announced the approval of Uceris (budesonide) extended-release tablets for mild to active UC. The company plans to launch the drug in March.

September 28, 2012

The Food and Drug Administration has approved a drug made by Abbott for treating ulcerative colitis.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Abbott for treating ulcerative colitis.

The agency announced Friday the approval of Humira (adalimumab) for moderate to severe UC. The drug was already approved for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, plaque psoriasis and juvenile idiopathic arthritis.

UC is a chronic disease that affects about 620,000 Americans, according to the National Institutes of Health.