Ista Pharmaceuticals Inc., an Irvine drug maker, said Wednesday that the Food and Drug Administration granted it a three-year exclusivity period on a new formulation of its flagship drug.
The FDA’s decision prevents a generic version of BromDay, a once-daily formulation of Ista’s Xibrom drug, from being considered until 2013.
BromDay is used to treat pain after cataract surgery.
Investors liked the news. Ista shares closed up 12% with a market value of about $147 million.
Separately, the drug maker said that it just shipped the first orders of BromDay, which was previously known as XiDay, to wholesalers and that it should be available in pharmacies beginning next week.
BromDay succeeds the twice-daily formulation of Xibrom. Ista plans to stop selling the latter early next year.
Xibrom is Ista’s longtime bellwether drug and has historically accounted for about 70% of its sales. Ista projects full-year revenue of $147 million to $165 million.
