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Ista's new drug application for Bepreve accepted for review by FDA

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IRVINE, Calif. — A new drug application for an eye drop indicated for ocular itching associated with allergic conjunctivitis has been accepted for review by the U.S. Food and Drug Administration, Ista Pharmaceuticals announced in a press release.

Ista filed the new drug application in November after positive phase 3 clinical data showed that the drug yielded statistically significant reductions in ocular itching and symptoms of ocular allergy with no serious ocular side effects.

Ista expects a standard 10-month review of the drug, called Bepreve (bepotastine ophthalmic solution), and has received a user fee action date of Sept. 12.