FDA grants Durezol priority review status
Sirion Therapeutics Inc. h
as received FDA approval for its New Drug Application (NDA) for Durezol(TM). The FDA has granted the drug priority review, which means that the review would be completed in six months from the date of receipt of the NDA. The NDA is for Sirion Therapeutics’ investigational compound Durezol(TM) (difluprednate ophthalmic emulsion) 0.05%, a twice-daily steroid, as a treatment for postoperative ocular inflammation.
