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

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
Envision Pharma Group

We are a global leader in the medical affairs space. Our purpose-built software and scientific solutions make us a unique...

Latest intelligence

Planning your clinical trial? Why you need to engage patients sooner
It’s highly likely that clinical studies are deterring patients based on decisions made in the early stages, such as during planning and design....
Patient-centricity in improving patient recruitment advertising
This blog looks into the importance of concepts and patient centricity in patient recruitment....
AI and life sciences
AI: the smart money is on the smart thinking
Looking at the three key areas where AI is being applied: drug discovery, clinical decision-making and clinical trials...

Infographics