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news.ISTA Pharmaceuticals has received the US Food and Drug Administration (FDA) approval for its supplemental new drug application (sNDA) for BromDay (bromfenac ophthalmic solution) 0.09%, as a once-daily prescription eye drop.
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BromDay is designed for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction.
ISTA expects to launch BromDay (formerly referred to as XiDay) prior to the end of 2010.
ISTA president and CEO Vicente Anido said that BromDay is the once-daily ophthalmic nonsteroidal anti-inflammatory drug (NSAID) for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction.
"BromDay is an important addition to our growing prescription eye and allergy product portfolio. Within just a few weeks, our expanded sales force will be ready to promote BromDay to US based ophthalmologists, along with BEPREVE, our recently launched eye drop for the treatment of itching associated with allergic conjunctivitis, Anido said.
"Since the BromDay approval process required additional clinical investigations beyond those conducted for the original approval of XIBROM 0.09%, we are seeking a three-year exclusivity period under the Drug Price Competition and Patent Term Restoration Act, the Hatch-Waxman Act."