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
Market Access Transformation

Market Access Transformation (MAT), founded by industry veterans Baiju Aurora and Paul Howard, specializes in developing cutting edge technologies that...

Latest intelligence

Australian Flu and the dilemma of naming diseases
...
Wearables and Healthcare
What place do wearables have in affecting actual patient health outcomes and can they contribute to the NHS’s sustainability agenda? Or are they just the latest fad?...
What does a future-proof rep look like?
Businesses can no longer afford to push ahead with the traditional Key Account Management model....

Infographics