How will Novartis notify providers and patients?
On April 2, 2008, Novartis will notify healthcare providers treating patients under the treatment IND protocol in writing. 5. How will this impact patients receiving Zelnorm under the treatment IND? Novartis will continue to supply Zelnorm only for emergency use. An emergency situation is defined as one that is immediately life-threatening or serious enough to qualify for hospitalization. 6. What other treatment options are available for patients? There is no other FDA approved drug to treat IBS-C. There are options available that could relieve some of the symptoms of IBS. 7. How will FDA aid patients during this process? The FDA can authorize use of Zelnorm for emergency uses only. Physicians with patients who may qualify for treatment with Zelnorm for emergency use may contact FDA’s Division for Drug Information about the emergency IND process at druginfo@fda.hhs.gov. 8. What does FDA recommend patients do? Patients should speak with their physicians to learn whether they might quali
