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news.Sirion Therapeutics has said that its new drug application or NDA for Durezol has been accepted by the FDA and granted priority review.
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Sirion is seeking approval for Durezol (difluprednate ophthalmic emulsion) 0.05%, a twice-daily steroid, as a treatment for postoperative ocular inflammation.
Priority review is granted by the FDA to those drugs that have the potential to provide a significant improvement compared to marketed products. This designation results in a review period of six months from the date of receipt of the NDA. The FDA has issued an action date of June 26, 2008 under the Prescription Drug User Fee Act (PDUFA).