Ampligen Approval Status

  • FDA approved: No
  • Brand name: Ampligen
  • Generic name: rintatolimod
  • 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

DateArticle
Feb  5, 2013Hemispherx Biopharma Receives Complete Response Letter From FDA on Ampligen New Drug Application for Chronic Fatigue Syndrome
Dec 27, 2012FDA Advisory Committee Makes Recommendations on Ampligen for Chronic Fatigue Syndrome
Oct 23, 2012Hemispherx Biopharma Announces FDA Confirms Advisory Committee Meeting on December 20, 2012
Sep 24, 2012Hemispherx Biopharma Announces FDA Advisory Committee Will Review Ampligen for Chronic Fatigue Syndrome
Aug 14, 2012FDA Accepts Complete Response Submission Regarding the Ampligen New Drug Application for Chronic Fatigue Syndrome
Aug  1, 2012Hemispherx Biopharma Files Complete Response With the FDA Regarding Its Ampligen New Drug Application for Chronic Fatigue Syndrome
Mar  7, 2008Hemispherx Biopharma Reaches Agreement With FDA on Specific Steps to Achieve Complete NDA on Proposed CFS Treatment Ampligen
Jan  9, 2008Hemispherx Biopharma Addresses FDA Questions On Ampligen NDA
Oct 11, 2007Hemispherx Biopharma Files New Drug Application for Ampligen as Treatment for Chronic Fatigue Syndrome

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