Please login to the form below

Not currently logged in
Email:
Password:

FDA reveals restricted use of Novartis' Zelnorm

The FDA permits the restricted use of constipation-predominant IBS drug Zelnorm under a treatment investigational new drug protocol

The FDA has permitted the restricted use of constipation-predominant IBS drug Zelnorm (tegaserod) under a treatment investigational new drug protocol.

The ruling also includes the treatment of chronic idiopathic constipation (CIC) in women younger under 55 years of age who meet specific guidelines. Zelnorm will remain off the market for general use.

Patients with a serious or life-threatening disease or condition who are not enrolled in a clinical trial may be treated with a drug not approved by the FDA. Such use is allowed within guidelines called a treatment IND, when no comparable or satisfactory alternative drug or therapy is available. These patients must meet strict criteria and have no known or pre-existing heart problems and be in critical need of this drug.

In FY06, Zelnorm sales were USD 561m, of which US sales accounted for USD 488m. Novartis revised its FY07 local currency sales growth outlook as a result and said it expected sales to grow above five percent. The company continues to stress that no causal relationship exists between ischemic CV events and tegaserod.

30th July 2007

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Kantar Health

Kantar Health is a leading global healthcare consulting firm and trusted advisor to many of the world’s leading pharmaceutical, biotech,...

Latest intelligence

segmentation_pie_thumb.jpg
If you’re not thinking segmentation, you’re not thinking
Having a background in market research I’ve been lucky to work on a number of customer segmentations in my time but working in creative communications it is still too rare...
Improving Outcomes in the Treatment of Opioid Dependence Highlights Report
The 16th annual ‘Improving Outcomes in the Treatment of Opioid Dependence’ (IOTOD)conference took place at the Hilton Madrid Airport hotel on 15–16 May 2018....
Londonvelophobia (fear of cycling in London) – debunked
...

Infographics