IBS and IBD In The News

Zelnorm Not Approved by FDA

Novartis June 18, 2001

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The Food and Drug Administration has issued a "not approvable" letter to Novartis in response to a request for marketing approval of Zelnorm. Zelnorm was created for use by women who suffer from predominantly constipating form of Irritable Bowel Syndrome (IBS). The FDA has asked Novartis for more information about patients using Zelnorm who undergo gall bladder surgery. At this time there is no mention of when the FDA may schedule another review for Zelnorm.

From the Novartis press release:

"We have received many patient letters requesting help, and consequently we are committed to making Zelnorm available for women who suffer from the debilitating symptoms of IBS," said Thomas Ebeling, CEO, Novartis Pharma AG. "We are disappointed by the FDA's decision, but remain confident in Zelnorm's ability to bring relief to many of the millions of patients suffering from the often life-altering symptoms of IBS." He added that "Novartis maintains its outlook for double digit pharmaceuticals sales growth which is expected to be in line with or above the market in 2001 and 2002".