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Ulcerative Colitis - Maintenance News (Page 2)
FDA Approves Xeljanz XR (tofacitinib) Extended-Release Tablets for the Treatment of Ulcerative Colitis
December 12, 2019 - Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved Xeljanz XR (tofacitinib) extended-release 11 mg and 22 mg tablets for the...
FDA Medwatch Alert: FDA Approves Boxed Warning About Increased Risk of Blood Clots and Death with Higher Dose of Tofacitinib (Xeljanz, Xeljanz XR)
July 26, 2019 – The U.S. Food and Drug Administration has approved new warnings about an increased risk of blood clots and of death with the 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz...
FDA Approves Ixifi (infliximab-qbtx), a Biosimilar to Remicade
December 13, 2017 – Pfizer Inc. (NYSE:PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved Ixifi (PF-06438179, infliximab-qbtx), a chimeric...
FDA Approves Cyltezo (adalimumab-adbm), a Biosimilar to Humira
Ridgefield, Conn., August 29, 2017 – Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved Cyltezo, a biosimilar to Humira, in a p...
FDA Approves Renflexis (infliximab-abda), a Biosimilar to Remicade
INCHEON, Korea – April 24, 2017 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Renflexis (infliximab-abda), a biosimilar referencing Rem...
FDA Approves Amjevita (adalimumab-atto), a Biosimilar to Humira
September 23, 2016 – The U.S. Food and Drug Administration today approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases. Amjevita is approved...
FDA Approves Uceris (budesonide) Rectal Foam for Ulcerative Colitis
RALEIGH, N.C., October 8, 2014 – Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Food and Drug Administration (FDA) has granted final approval for Uceris (budesonide) rectal foam...
FDA Approves Simponi to Treat Ulcerative Colitis
May 15, 2013 – The U.S. Food and Drug Administration today approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis. Simponi works by blocking...
Warner Chilcott Announces FDA Approval of New Ulcerative Colitis Product Delzicol
DUBLIN, Ireland, Feb. 5, 2013 – Warner Chilcott plc today announced that the United States Food and Drug Administration (FDA) has approved its new 400 mg mesalamine product indicated for the...
Lialda (Mesalamine) Now Approved in U.S. for Maintenance of Remission of Ulcerative Colitis
Lialda has been indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis and is now also approved for the maintenance of remission of ulcerative colitis ...
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