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April 2, 2008
Following the US marketing suspension of Zelnorm® (tegaserod maleate) Novartis initiated a restricted access program called a treatment IND in collaboration with the Food & Drug Administration (FDA) in July 2007, so that patients in need of this medicine can be considered for treatment. On April 2, 2008, after more than eight months of availability, the company has re-assessed the program and has made a decision to close it. Novartis is in the process of communicating this decision to physicians participating in the program. Patients who had access to Zelnorm via this program are instructed to discuss alternative treatment options with their physicians.
FDA has noted that for patients who have an emergency situation, defined as one that is immediately life-threatening or serious enough to qualify for hospitalization, there may be an alternative (an emergency IND) option. Physicians may inquire about this potential access option by contacting the FDA CDER Division of Drug Information at 301-796-3400 or www.fda.gov/cder.
Frequently Asked Questions
| What is irritable bowel syndrome (IBS) and chronic idiopathic constipation (CIC) | |
| IBS is a disorder characterized by abdominal pain or discomfort, bloating, and altered bowel function. An estimated 12 million Americans suffer from IBS with constipation. Many have symptoms for five to 10 years, which trigger missed work days and often prevent them from participating in everyday activities with their family and friends. | |
| Chronic constipation (or chronic idiopathic constipation) accounts for more than 5.7 million constipation-related outpatient visits each year, with more than 990,000 visits to emergency rooms and more than 580,000 to hospital outpatient facilities. It leads to more than 282,000 in-patient hospitalizations with constipation as the primary diagnosis. | |
| What is the status of the treatment IND in the US? | |
| Following the market suspension of Zelnorm in March 2007, Novartis initiated an access program called a treatment IND in collaboration with the FDA. On April 2, 2008, Novartis communicated to physicians participating in the tIND a decision to close the program. | |
| What is the alternative option for patients who were enrolled in the tIND? | |
| Patients who had access to Zelnorm via the tIND are instructed to discuss alternative treatment options with their physicians. FDA has noted that for patients who have an emergency situation, defined as one that is immediately life-threatening or serious enough to qualify for hospitalization, there may be an alternative option available through the FDA. Physicians may inquire about this potential access option by contacting the FDA CDER Division of Drug Information at 301-796-3400 or www.fda.gov/cder. | |
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