Alfasigma USA , Inc. announces the withdrawal of the NDA for ZELNORM ® (tegaserod) effective June 30th . Alfasigma USA , Inc. will no longer make the product available in the US marketplace.
| COVINGTON, La., June 30, 2022 /PRNewswire/ -- Alfasigma USA, Inc. announces the withdrawal of the NDA for ZELNORM® (tegaserod) effective June 30th. Alfasigma USA, Inc. will no longer make the product available in the US marketplace. Please know that this decision was not made lightly nor was it based on product efficacy, safety or because of an imposed recall. Our decision to remove ZELNORM® (tegaserod) from the market is strictly a business decision. Patients will continue to have access to ZELNORM® (tegaserod) for as long as the existing supply of product remains in the trade channel. Alfasigma USA, Inc. urges patients and Health Care Providers to discuss alternative therapies that will meet patient needs. Important Safety Information Indication Warnings and Precautions Cardiovascular Ischemic Events, Including Major Adverse Cardiovascular Events (MACE): Stroke, MI, and cardiovascular death have been reported in adults taking ZELNORM® who had an increased risk of developing an adverse cardiovascular event based on their medical history. Ischemic Colitis: Ischemic colitis and other forms of intestinal ischemia have been reported postmarketing in patients receiving ZELNORM® (R). Discontinue ZELNORM® (R) in patients who develop symptoms of ischemic colitis, such as rectal bleeding, bloody diarrhea, or new or worsening abdominal pain. Volume Depletion Associated with Diarrhea: In postmarketing experience, serious consequences of diarrhea including hypovolemia, hypotension, and syncope have been reported in patients treated with ZELNORM® (R). Avoid use of ZELNORM® (R) in patients who are currently experiencing or frequently experience diarrhea. Instruct patients to discontinue ZELNORM® (R) and contact their healthcare provider if severe diarrhea, hypotension, or syncope occur. Suicidal Ideation and Behavior: Monitor all ZELNORM® (R)-treated patients for clinical worsening of depression and emergence of suicidal thoughts and behaviors, especially during the initial few months of treatment. Counsel family members and caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Instruct patients to immediately discontinue ZELNORM® (R) and contact their healthcare provider if their depression is persistently worse or they are experiencing emergent suicidal thoughts or behaviors. Common Adverse Reactions (incidence >2% and greater than placebo) Use in Specific Populations
For more information, please see the Medication Guide and full Prescribing Information for ZELNORM® (R) at www.ZELNORM® (R)us.com. In order to assist Alfasigma USA, Inc. in monitoring safety, we encourage all healthcare professionals to report any adverse events to Alfasigma USA, Inc. at 1-844-639-9726 or to the FDA at 1-800-FDA-1088 or online at http://www.fda.gov/Safety/MedWatch/ . If you have any additional questions, please contact Alfasigma USA, Inc. Medical Information at 1-844-639-9726 between the hours of 8:00 a.m. and 5:00 p.m. EST. About Alfasigma USA, Inc. Alfasigma USA, Inc. is the American affiliate of Alfasigma, a leading Italian pharmaceutical company. Alfasigma is present in more than 90 countries, with a workforce of around 3,000 people and 5 manufacturing plants. Alfasigma USA, Inc. distributes a portfolio of prescription nutritional products to help individuals who are suffering from GI disorders (VSL#3®) (ZELNORM®), major depressive disorder (DEPLIN®), diabetic peripheral neuropathy (METANX®), and mild cognitive impairment (CerefolinNAC®). Alfasigma USA, Inc. is building on their commitment to making ‘Pharmaceuticals with Passion’ in the US. For more information, please visit www.alfasigmausa.com or email info@alfasigma.com. Media Contact:
SOURCE Alfasigma USA, Inc. |
View original content: