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FDA approves allergy drug Elestat

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U.S. regulators have approved a new topical medication for the prevention of itching associated with allergic conjunctivitis, according to a letter issued by the Food and Drug Administration.

Recommended dosing of Elestat (epinastine HCl ophthalmic solution, Allergan) is one drop in each eye twice daily. Epinastine is a topically active, direct H1-receptor antagonist and an inhibitor of the release of histamine from mast cells, according to Allergan packaging materials.

Allergan filed its application for approval of the drug in Dec. 2002, according to the FDA letter.

Results of use of epinastine in a pediatric population were presented at this year’s European Society of Ophthalmology. Researchers found the drug to be well-tolerated with no significant adverse reactions in children over the age of 3. The current U.S. approval is for use in adults only, however.