Showing posts sorted by date for query eluxadoline. Sort by relevance Show all posts
Showing posts sorted by date for query eluxadoline. Sort by relevance Show all posts

Thursday, August 27, 2015

Actavis announces FDA approval of VIBERZI (eluxadoline) for IBS-D treatment

In continuation of my update on VIBERZI (eluxadoline)



Actavis plc,  announced today that VIBERZI™ (eluxadoline) was approved by the Food and Drug Administration (FDA) as a twice-daily, oral treatment for adults suffering from irritable bowel syndrome with diarrhea (IBS-D). VIBERZI (eluxadoline) has mixed opioid receptor activity, it is a mu receptor agonist, a delta receptor antagonist, and a kappa receptor agonist.

"The FDA's approval of VIBERZI is the first step to providing physicians with a new, evidence-based, treatment option for their adult patients with IBS-D," said David Nicholson, Executive Vice President, Actavis Global Brands R&D. "At Actavis, we are dedicated to providing new treatment options, and the development of new agents that help address the most bothersome symptoms of IBS-D. We are very pleased to be working with the FDA to advance this IBS-D treatment and we eagerly await DEA scheduling determination later this year."




Eluxadoline.png

Ref : http://pubchem.ncbi.nlm.nih.gov/compound/11250029#section=Canonical-SMILES


Actavis announces FDA approval of VIBERZI (eluxadoline) for IBS-D treatment

Tuesday, September 16, 2014

Actavis Announces FDA Acceptance for Filing of NDA for Eluxadoline

Actavis plc (NYSE: ACT) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Actavis' New Drug Application (NDA) for eluxadoline, an investigational drug for the treatment of diarrhea and abdominal pain in men and women with diarrhea predominant Irritable Bowel Syndrome (IBS-D). Actavis' NDA for eluxadoline has been granted priority review status by the FDA.