Santarus, Inc., Launcher of Drug UCERIS (New Treatment for IBD, Asthma, n-i Rhinitis) Is Delayed by FDA - Full Article Posted

The expected new drug, Uceris, aims to treat asthma, non-infectious rhinitis, and inflammatory bowel disease.

Uceris
Uceris is an investigational oral tablet that releases Budesonide throughout the length of the colon.

Budesonide is a type of steroid used for the treatment of asthma, non-infectious rhinitis, and inflammatory bowel disease.

(My personal opinion about this drug... Doesn't sound too bad.  The time release form of prednisone doesn't effect your entire body with horrific side-effect, like it does with the traditional prednisone tablet that is digested and released throughout  your bloodstream (ultimately reaching all areas of your body)  Since it is released in the colon, the drug is pretty much confined to the colon, reducing  the overall number of the steroid's medication side-effects 

FDA extends review time for Santarus bowel drug-chicagotribune.com:

Reuters

5:16 p.m. CDT, August 13, 2012

(Reuters) - Santarus Inc said U.S. health regulators extended the action date on its experimental bowel disease drug by three months, sending its shares down as much as 8 percent in extended trade.

The company said the U.S. Food and Drug Administration extended the action date to January 16, 2013 from October 16 this year, as it needs more time for a full review of the submitted information.

Santarus said FDA will communicate proposed labeling and any required post-marketing requirement requests by December 12.

Santarus expects to launch the drug, Uceris, in about two months after determining the final product label.Uceris

Uceris is an investigational oral tablet that aims to release Budesonide throughout the length of the colon.

Budesonide is a type of steroid used for the treatment of asthma, non-infectious rhinitis, and inflammatory bowel disease.

Shares of the company fell 8 percent to $5.87 in extended trade. They closed at $6.41 on Monday on the Nasdaq.

(Reporting by Prateek Kumar in Bangalore)



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