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Moxatag Approval History

  • FDA approved: Yes (First approved January 23rd, 2008)
  • Brand name: Moxatag
  • Generic name: amoxicillin
  • Dosage form: Extended Release Tablets
  • Previous name: Amoxicillin PULSYS
  • Company: MiddleBrook Pharmaceuticals, Inc.
  • Treatment for: Tonsillitis/Pharyngitis

Moxatag is a once-daily extended-release formulation of the penicillin antibiotic amoxicillin indicated for the treatment of adults and pediatric patients 12 years and older with pharyngitis and/or tonsillitis secondary to Streptococcus pyogenes (commonly referred to as strep throat).

Development History and FDA Approval Process for Moxatag

Jan 24, 2008Approval FDA Approves MiddleBrook's Moxatag - Amoxicillin PULSYS - for Pharyngitis/Tonsillitis in Adolescents and Adults
May 22, 2007Advancis Pharmaceutical Announces FDA Acceptance of Amoxicillin PULSYS NDA
Mar 24, 2007Advancis Pharmaceutical Resubmits New Drug Application for Once-Daily Amoxicillin PULSYS

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