Restanza Approval Status

  • FDA approved: No
  • Brand name: Restanza
  • Generic name: cethromycin
  • Company: Advanced Life Sciences Holdings, Inc.
  • Treatment for: Pneumonia

Restanza (cethromycin) is a once-a-day oral antibiotic in development as a treatment for mild-to-moderate community acquired pneumonia (CAP).

FDA Approval Status for Restanza

DateArticle
Aug  6, 2009Advanced Life Sciences Receives Complete Response Letter From FDA for Restanza (Cethromycin) in Community Acquired Pneumonia
Jun  3, 2009Advanced Life Sciences Announces Outcome of FDA's Anti-Infective Drugs Advisory Committee Review of Restanza (cethromycin)
May 29, 2009Advanced Life Sciences Announces Posting of Briefing Documents for FDA Advisory Committee Meeting on Restanza (cethromycin)
Feb 27, 2009Advanced Life Sciences Receives Notice of Planned Cethromycin Review by FDA Advisory Committee
Dec  3, 2008Advanced Life Sciences Announces Cethromycin NDA Accepted for Filing by FDA for Community Acquired Pneumonia
Oct  1, 2008Advanced Life Sciences Announces NDA Submission for Cethromycin in Community Acquired Pneumonia
Apr 10, 2008Advanced Life Sciences Announces Plan to Submit NDA for Cethromycin

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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