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
| Date | Article |
|---|
| 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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