Bepreve™ Eye Drops from ISTA Obtain Approval of FDA Dermatologic and Ophthalmic Drugs Advisory Committee

June 29, 2009

ISTA Pharmaceuticals, Inc. has announced that the FDA Dermatologic and Ophthalmic Drugs Advisory Committee has recommended approval of Bepreve™ (bepotastine besilate ophthalmic solution) 1.5% for the treatment of itching associated with allergic conjunctivitis. Bepreve is a non-sedating, highly selective antagonist of the histamine receptor and has a stabilizing effect of mast cells.

The committee’s vote was unanimous after reviewing the safety and efficacy information from the clinical studies. Although the FDA does not have to follow the recommendation of the Committee, the evaluation is usually considered when reviewing pending applications for approval. The FDA has assigned September 12, 2009 as the Prescription Drug User Fee Action Date.

Read the release.

 

 



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