Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The US Food and Drug Administration (FDA) has granted ISTA Pharmaceuticals 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 Hatch-Waxman Act.
Subscribe to our email newsletter
Bromday (formerly referred to as XiDay), an once-daily 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.
As per the Hatch-Waxman Act, the FDA may not approve an abbreviated new drug application for a generic version of Bromday until October of 2013.
Ista has recently shipped the first orders of Bromday to wholesalers and expects Bromday to be available in pharmacies beginning the week of 22 November 2010.