Once-daily bromfenac given 3-year marketing exclusivity

Irvine, CA-The FDA has granted 3 years of marketing exclusivity to the U.S. marketer of the once-daily formulation of 0.09% bromfenac ophthalmic solution (Bromday, ISTA Pharmaceuticals).

In October, the formulation became the first and only once-daily prescription eye drop for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction. It is approved for dosing once-daily beginning 1 day before surgery, on the day of surgery, and continuing for the first 14 days after surgery.

The drug was expected to become available in pharmacies in late November. The company expects to discontinue its twice-daily formulation (Xibrom) of the nonsteroidal anti-inflammatory compound early next year.

Under the Drug Price Competition and Patent Term Restoration Act, commonly known as the Hatch-Waxman Act, the FDA may not approve an abbreviated new drug application for a generic version of the once-daily bromfenac formulation until October 2013.