Hemispherx Biopharma, Inc. (HEB) announced that ANMAT, the agency responsible for the national regulation of drugs, foods and medical technology in Argentina, has approved the use of Alferon N Injection in Argentina for any patient that fails or becomes intolerant to treatment with recombinant interferon.
Alferon N Injection is an FDA-approved natural interferon and, as Naturaferon, is already approved in Argentina for the treatment of refractory or recurring external condylomata acuminata.
Hemispherx noted that both the use of its existing inventory of Alferon N Injection for sale in Argentina as well as the use of drug to be manufactured in the future will require FDA approval. Therefore the timelines for when drug can be shipped to Argentina and when resulting revenues in Argentina will occur cannot be determined at this time, the company said.
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