Pharmaceutical Business review

ISTA Pharma Bromday gets three years marketing exclusivity grant

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.