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`FDA grants three years of marketing exclusivity to ISTA's BROMDAY
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`March 14, 2016
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`FDA grants three years of marketing exclusivity to
`ISTA's BROMDAY
`Published on November 18, 2010 at 12:39 AM · No Comments
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`ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), today announced the U.S. Food and Drug
`Administration (FDA) has granted the Company three years of marketing exclusivity for
`BROMDAY™ (bromfenac ophthalmic solution) 0.09%, as provided under the Drug Price
`Competition and Patent Term Restoration Act, commonly known as the HatchWaxman
`Act. BROMDAY (formerly referred to as XiDay), the first and only oncedaily
`prescription eye drop for the treatment of postoperative inflammation and reduction of
`ocular pain in patients who have undergone cataract extraction, was approved by the
`FDA in October of 2010. Under the HatchWaxman Act, the FDA may not approve an
`Abbreviated New Drug Application for a generic version of BROMDAY until October of
`2013.
`
`ISTA also announced it recently shipped the first orders of BROMDAY to wholesalers
`and expects BROMDAY to be available in pharmacies beginning the week of November
`22, 2010. The ISTA sales force has begun detailing BROMDAY to ophthalmologists,
`and the company expects to discontinue the twicedaily XIBROM product in early 2011.
`
`Source:
`ISTA Pharmaceuticals, Inc.
`
`Be the first to rate this post
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`Posted in: Pharmaceutical News
`Tags: Allergy, AntiInflammatory, Cataract, Conjunctivitis, Contact Lens, Dry Eye, Glaucoma, New
`Drug Application, Pain
`
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