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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).

Development Status and FDA Approval Process 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

Further information

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