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Durezol Approval History

  • FDA approved: Yes (First approved June 23rd, 2008)
  • Brand name: Durezol
  • Generic name: difluprednate
  • Dosage form: Ophthalmic Emulsion
  • Company: Sirion Therapeutics, Inc.
  • Treatment for: Postoperative Ocular Inflammation

Durezol (difluprednate ophthalmic emulsion) is a topical steroid for the treatment of postoperative ocular inflammation and pain.

Development History and FDA Approval Process for Durezol

Jun 24, 2008Approval Sirion Therapeutics Announces FDA Approval of Durezol for Treatmentof Postoperative Ocular Inflammation and Pain
Feb 27, 2008Sirion Therapeutics Receives NDA Acceptance and Priority Review From the FDA for Durezol in the Treatment of Postoperative Ocular Inflammation

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