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Bepreve FDA Approval History

FDA Approved: Yes (First approved September 8, 2009)
Brand name: Bepreve
Generic name: bepotastine
Dosage form: Ophthalmic Solution
Company: ISTA Pharmaceuticals, Inc.
Treatment for: Conjunctivitis, Allergic

Bepreve (bepotastine ophthalmic solution) is an antihistamine and mast cell stabilizer for treatment of the symptoms of allergic conjunctivitis.

Development timeline for Bepreve

DateArticle
Sep  9, 2009Approval Ista Pharmaceuticals' Bepreve Receives FDA Approval for the Treatment of Ocular Itching Due to Allergies
Jun 28, 2009Dermatologic and Ophthalmic Drugs Advisory Committee Unanimously Recommends Bepreve for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis
Jun  2, 2009ISTA Pharmaceuticals Announces FDA Advisory Committee to Review Bepreve for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis
Jan 15, 2009ISTA Pharmaceuticals' New Drug Application for Bepreve Accepted for Review by U.S. Food and Drug Administration
Nov 14, 2008ISTA Pharmaceuticals Files New Drug Application with U.S. FDA for Bepreve

See also

Bepreve (bepotastine) Consumer information

Further information

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