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Advanced Therapy For Cholestinol Metabolism |
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ChenodalTM 250 mg (chenodiol tablets) Approved By The FDA
We are pleased to announce that on October 22, 2009 The Food and Drug Administration (FDA) issued an approval for the Manchester Pharmaceuticals, Inc.™ version of chenodiol 250mg tablets, which will be marketed in the United States under the trade name of Chenodal™. Chenodal is now available for shipment to patients. Manchester is committed to ensuring all patients have access to Chenodal. Manchester Pharmaceuticals, Inc. has partnered with Centric Health Resources in the Chenodal Total Care Program (CTCP). CTCP provides patients with one point of contact for all their needs related to securing an ongoing supply of Chenodal. CTCP has a team of highly-trained professionals with extensive experience in assisting individuals with rare chronic conditions through our patient-care programs, disease management programs and reimbursement/billing services. CTCP will assist patients with all their insurance needs, including helping patients who do not currently have insurance coverage. Centric Health Resources will fill each patient’s prescription and provide free delivery of Chenodal direct to their home or business. CTCP will also offer patients a comprehensive compliance system to improve adherence to the specific directions given them by their physician. Patients and physicians are encouraged to contact CTCP now at 1-866-758-7068 to begin the process of setting up their first order of Chenodal or to obtain more information about the upcoming availability of Chenodal. Customer Service representatives are available to assist you Monday through Friday 7:00 AM to 6:00 PM CST. The US approval of Chenodal now provides physicians and their patients with a chenodiol product that meets all FDA requirements for product integrity, quality, safety and effectiveness. Moreover, FDA approval of Chenodal also allows for direct regulation of the manufacturing facilities and procedures employed in the production of the product to ensure Chenodal’s consistent product integrity. Prior to the FDA approval of Chenodal many patients were importing an unapproved version of chenodiol from Europe. Because the FDA cannot regulate the quality, safety and effectiveness of unapproved drugs manufactured outside the United States, they prohibit the importation of unapproved drugs into the United States except in the rare situation where a medically necessary product is not available domestically, as was the case with chenodiol. With the approval of Chenodal, all future importation of chenodiol from outside the United States is no longer necessary, allowing patients and physicians to be compliant with the United States Federal, Food, Drug and Cosmetic Act.
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