Ista Pharmaceuticals Inc. (ISTA) said that the FDA advisory committee has recommended the approval of Bepreve 1.5% as an eye drop treatment for ocular itching associated with allergic conjunctivitis.
The Committee voted unanimously 7 to 0 in favor of approving Bepreve after reviewing comprehensive safety and efficacy data from Ista's clinical program.
The FDA has assigned a Prescription Drug User Fee Action Date of September 12, 2009.
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