Notice of Lisodren’s Registration Cancellation
Moksha8 Brasil Indústria e Comércio de Medicamentos Ltda (“M8 Pharmaceuticals”) announces that on May 7, 2024, it requested that the Brazilian Health Regulatory Agency (“ANVISA”) cancel the registration of the drug Lisodren (mitotane) 500 mg, which was approved on June 3, 2024. Additionally, ANVISA was notified of the definitive discontinuation of the product’s importation on March 25, 2022, as required by RDC No. 18 of April 4, 2014. We clarify that the cancellation of the product’s registration is due to economic unfeasibility within Brazilian territory and a consensual decision following discussions with ANVISA and CMED, led by M8 and HRA Pharma Rare Diseases, the product’s international owner.
The company understands how important this medication is to patients, their families, and healthcare professionals. We emphasize that HRA Pharma Rare Diseases, the international owner of Lisodren (mitotane), will continue to manufacture and market the medication worldwide. Thus, Brazilian patients will be able to import Lisodren (mitotane) in accordance with current health regulations, for individual use and with labeling consistent with the registration in the country of origin. The importation by individuals of goods or products subject to health control is regulated by Chapter XII of Collegiate Board Resolution (RDC) 81, dated November 5, 2008, as amended by RDC 28, dated June 28, 2011. For more details on how to import Lisodren (mitotane) for personal and individual use, please contact HRA Pharma Rare Diseases (jcardona@esteve.com).
Lisodren (mitotane) is indicated for the treatment of advanced adrenal cortical carcinoma, also known as adrenocortical carcinoma, a very rare type of cancer of the adrenal glands that affects 0.7 to 2 people per million annually. The treatment of choice for this type of tumor, when diagnosed early, is surgery.
It is important for patients and physicians to discuss the best course of treatment. M8 Pharmaceuticals emphasizes that it is available to patients to answer any questions through its Customer Service Department (SAC). The service can be reached by phone at 0800 601 9392 or by email at br.sac@m8pharma.com