Content about Mesalazine

February 8, 2013
FDA approves Warner Chilcott ulcerative colitis drug

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.

May 10, 2012
Watson seeks approval for generic ulcerative colitis drug

Generic drug maker Watson Pharmaceuticals is hoping to be the first to market a generic version of a drug used to treat ulcerative colitis, the company said.

PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals is hoping to be the first to market a generic version of a drug used to treat ulcerative colitis, the company said.

Watson announced that it had filed with the Food and Drug Administration through a subsidiary for melamine delayed-release tablets, a generic version of Shire Development's Lialda, in the 1.2-g strength. Watson's filing included a Paragraph IV certification, a legal assertion that Lialda's patent protection is invalid, unenforceable or won't be infringed.

October 11, 2011
Zacks: Warner Chilcott can withstand generic threats

Drug maker Warner Chilcott's diversified portfolio of drugs will help it weather generic challenges to its patents, according to a new report by Zacks Investment Research.

NEW YORK — Drug maker Warner Chilcott's diversified portfolio of drugs will help it weather generic challenges to its patents, according to a new report by Zacks Investment Research.

July 18, 2011
Shire's Lialda receives FDA approval

The Food and Drug Administration has approved a drug made by Shire for treating ulcerative colitis, the British drug maker said Monday.

PHILADELPHIA — The Food and Drug Administration has approved a drug made by Shire for treating ulcerative colitis, the British drug maker said Monday.

Shire announced the approval of Lialda (mesalamine) delayed-release tablets for the maintenance of remission in patients with the disease.

The drug was already approved for inducing remission in patients with ulcerative colitis, an inflammatory disease that affects the colon and causes chronic inflammation, sores and ulcers.

February 22, 2011
Prasco agrees to distribute authorized generic of Pentasa

Prasco Labs will distribute an authorized generic version of an ulcerative colitis treatment made by Shire in the event that any other company steps forward to file an abbreviated new drug application for the drug.

CINCINNATI — Prasco Labs will distribute an authorized generic version of an ulcerative colitis treatment made by Shire in the event that any other company steps forward to file an abbreviated new drug application for the drug.