Hemispherx Biopharma Inc. Jan. 11 announced that the Food and Drug Administration has granted an extension for the company to modify its new drug application seeking approval of Ampligen for the treatment of chronic fatigue syndrome (CFS).
The Philadelphia-based company said it asked for the extension to have time to respond to a complete response letter that it received from FDA in 2009. The extension will remain open while the company submits an amended NDA, Hemispherx said.
Ampligen is a double-stranded RNA drug product, which is administered intravenously. It also is in clinical development to treat HIV, renal cell carcinoma, ...
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