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Durezol Approval History

FDA Approved: Yes (First approved June 23, 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

DateArticle
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

Further information

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