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Oracea Approval History

  • FDA approved: Yes (First approved May 26th, 2006)
  • Brand name: Oracea
  • Generic name: doxycycline
  • Dosage form: Capsules
  • Company: CollaGenex Pharmaceuticals, Inc.
  • Treatment for: Rosacea

Oracea is a once-a-day capsule formulation of doxycycline, consisting a combination of immediate and delayed release beads. Oracea is indicated for the treatment of inflammatory lesions (papules and pustules) of rosacea in adult patients.

Development History and FDA Approval Process for Oracea

DateArticle
May 26, 2006Approval Oracea CollaGenex Pharmaceuticals, Inc. - Treatment for Rosacea
Oct  3, 2005CollaGenex Pharmaceuticals' New Drug Application for Oracea Accepted for Review by FDA; Target PDUFA Date is May 30, 2006
Aug  1, 2005CollaGenex Pharmaceuticals Files New Drug Application for Oracea

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