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ISTA submits sNDA for once-daily bromfenac
ISTA Pharmaceuticals Inc. has submitted a supplemental new drug application to the FDA for bromfenac ophthalmic solution dosed once-daily as a treatment for ocular inflammation and pain following cataract surgery.
Irvine, CA
-ISTA Pharmaceuticals Inc. has submitted a supplemental new drug application (sNDA) to the FDA for bromfenac ophthalmic solution dosed once-daily as a treatment for ocular inflammation and pain following cataract surgery.
The company markets a 0.09% bromfenac eye drop (Xibrom) for twice-daily use beginning 24 hours after cataract surgery. If the new dosing is approved, ISTA plans to market the once-daily topical non-steroidal anti-inflammatory compound under a different brand name (XiDay).
The company expects the review to be completed in about 6 months.
