U.S. Food and Drug Administration

June 8, 2017June 8, 2017

FDA Approves Mesalamine Delayed–Release Tablets, Generic of Lialda, for UC

News

The U.S. Food and Drug Administration (FDA) has given final approval for Zydus Cadila to market Mesalamine Delayed–Release Tablets USP, a generic version of Lialda, in the U.S. to treat ulcerative colitis (UC). The announcement follows news ... Read more

April 3, 2017

FDA Reports of Crohn’s Disease Treatment Side Effects Have Increased, Analysis Finds

News

Drugs used to treat Crohn’s disease and other autoimmune disorders are among those with the greatest number of reported side effects filed with the U.S. Food and Drug Administration (FDA), ... Read more

December 5, 2016

FDA Grants Orphan Drug Status to AbbVie’s Therapy for Pediatric Crohn’s Disease

News

The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to AbbVie’s investigational drug risankizumab for the treatment of pediatric patients with Crohn’s disease. Risankizumab (ABBV-066) selectively blocks ... Read more

April 11, 2016April 11, 2016

FDA Approves Inflectra, a Biosimilar to Remicade, to Treat Ulcerative Colitis and Crohn’s

News

Celltrion announced that the U.S. Food and Drug Administration (FDA) approved Inflectra (biosimilar infliximab) for all indications of the reference product Remicade (infliximab), marketed in the country by Janssen Biotech, Inc. ... Read more