AIM ImmunoTech’s Ampligen Receives Clearance from FDA for Exportation to Argentina for the Treatment of Severe Chronic Fatigue Syndrome
Important Milestone to Commercial Launch in Argentina Achieved
OCALA, FL / ACCESSWIRE / September 24, 2019 / AIM ImmunoTech (NYSE American:AIM), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers and immune-deficiency diseases - such as severe chronic fatigue syndrome (CFS) - has received clearance to export to Argentina from the U.S. Food and Drug Administration (FDA) its flagship drug Ampligen. In 2016, the company announced the approval of its New Drug Application (NDA) from Argentina's Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica (ANMAT) for the commercial sale of Ampligen for the treatment of CFS.
The FDA requires certain regulations be met in order to export a drug manufactured in the United States to a foreign country. In order to receive clearance to export to Argentina, AIM ImmunoTech submitted information on the drug approval processes and standards in Argentina and the issuance by ANMAT of its approval of Ampligen.
The FDA determined that the processes and standards applicable to drug approval in Argentina meet the requirements under section 802(b)(2) of the U.S. Federal Food, Drug and Cosmetic Act. Those requirements include expert review of safety and effectiveness, good manufacturing practice and quality controls, adverse experience reporting and control of drug labeling and promotion. To our knowledge, this is the first time in over ten years, and only the second time ever, the FDA has made this determination.
The FDA has informed the company that it intends to make public disclosure of its clearance with respect to the export of Ampligen to Argentina. The company believes that this disclosure may be posted on the FDA website or it may be published in the Federal Register.
