Ampligen Approval Status
- FDA approved: No
- Brand name: Ampligen
- Generic name: poly I:poly C12U
- Company: Hemispherx Biopharma, Inc.
- Treatment for: Chronic Fatigue Syndrome
Ampligen is an experimental nucleic acid therapeutic being developed for the potential treatment of Chronic Fatigue Syndrome (CFS).
FDA Approval Status for Ampligen
|Feb 5, 2013||Hemispherx Biopharma Receives Complete Response Letter From FDA on Ampligen New Drug Application for Chronic Fatigue Syndrome|
|Dec 27, 2012||FDA Advisory Committee Makes Recommendations on Ampligen for Chronic Fatigue Syndrome|
|Oct 23, 2012||Hemispherx Biopharma Announces FDA Confirms Advisory Committee Meeting on December 20, 2012|
|Sep 24, 2012||Hemispherx Biopharma Announces FDA Advisory Committee Will Review Ampligen for Chronic Fatigue Syndrome|
|Aug 14, 2012||FDA Accepts Complete Response Submission Regarding the Ampligen New Drug Application for Chronic Fatigue Syndrome|
|Aug 1, 2012||Hemispherx Biopharma Files Complete Response With the FDA Regarding Its Ampligen New Drug Application for Chronic Fatigue Syndrome|
|Mar 7, 2008||Hemispherx Biopharma Reaches Agreement With FDA on Specific Steps
to Achieve Complete NDA on Proposed CFS Treatment Ampligen|
|Jan 9, 2008||Hemispherx Biopharma Addresses FDA Questions On Ampligen NDA|
|Oct 11, 2007||Hemispherx Biopharma Files New Drug Application for Ampligen as
Treatment for Chronic Fatigue Syndrome|
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